Eli Lilly & Company

Sembra sia stata presa in modo positivo... :cool:

Eli Lilly and Co. (NYSE: LLY) Chief Executive Officer John Lechleiter will outline today the company's strategic plan and how it could impact Indiana. In a speech to the Economic Club of Indiana, company officials say Lechleiter will unveil a five-point strategy aimed at transforming Lilly. In recent years, Lilly has reduced its global workforce by thousands, trimmed layers of management and focused on collaborations with strategic partners. This year, Lilly has announced plans to sell, close or reposition its Tippecanoe Laboratories near Lafayette and sold its Greenfield Laboratories to Covance Inc.
 
Se la stava cavando bene nelle ultime sedute, ringraziamo JP Morgan e il suo downgrade! :D
Riflettori su domani, potrebbe essere una giornata da volumi, speriamo in acquisto per chi è dentro! OK!
 
Se la stava cavando bene nelle ultime sedute, ringraziamo JP Morgan e il suo downgrade! :D
Riflettori su domani, potrebbe essere una giornata da volumi, speriamo in acquisto per chi è dentro! OK!

Si, ma parliamoci chiaro... Io bazzico nelle conferenza mediche e la Lilly a parte cercare nuovi modi per prolungare il brevetto sulla duloxetina dal diabete all'incontineza urinaria ho visto poco. C'e' il blood thinner come tu hai detto ma vedi, quel mercato e' in mano all'eparina che non costa una mazza... :specchio:

Upside potential ne vedo poco a parte la possiblita' di un'esuberanza irrazionale collettiva se la FDA approva... :rolleyes:

Purtroppo ho creato un portfolio 10 anni fa' che doveva essere "long term", ma avrei dovuto disfarlo nel 2 mila e ristrutturarlo :wall:

Non ci perdo dato che ho in portfolio Nokia a meno di due dollari per azione :cool:
 
Si, ma parliamoci chiaro... Io bazzico nelle conferenza mediche e la Lilly a parte cercare nuovi modi per prolungare il brevetto sulla duloxetina dal diabete all'incontineza urinaria ho visto poco. C'e' il blood thinner come tu hai detto ma vedi, quel mercato e' in mano all'eparina che non costa una mazza... :specchio:
Upside potential ne vedo poco a parte la possiblita' di un'esuberanza irrazionale collettiva se la FDA approva... :rolleyes:

Pensavo che il Prasugrel fosse più importante visto che dovrebbe andare in concorrenza con il Plavix della Sanofi che ha grandi vendite.
Ma se vai alle conferenze mediche ne saprai certamente più di noi! :yes:

La mia idea era quella di entrare in zona 41-42$ e rivendere al prezzo obiettivo di 50$. Con l'eventuale approvazione del farmaco il target potrebbe cambiare; certo non è che mi aspetto salti mortali...
 
Per questo ho una diffidenza particolare nei titoli bio o medici... se non si e' nel campo e' praticamente impossibile prevederne gli sviluppi. :angry:
Ciononostante a volte ci provo... :rolleyes:
+0.56 :wall:
Meglio che in negativo...
 
:confused::confused::confused:

http://www.fool.com/investing/general/2008/09/25/another-win-for-disclosure.aspx

...Earlier this week, pharma giant Eli Lilly (NYSE: LLY) announced that in the coming year, it would begin disclosing the fees it pays to doctors for speaking arrangements and consulting work.

The interactions between pharmaceutical companies and the doctors who prescribe their drugs and help run their clinical trials have sometimes come under intense scrutiny. Critics have pointed out a potential conflict of interest in doctors prescribing drugs, then getting paid by those drugs' makers for one form of work or another....
 
:confused::confused::confused:

http://www.fool.com/investing/general/2008/09/25/another-win-for-disclosure.aspx

...Earlier this week, pharma giant Eli Lilly (NYSE: LLY) announced that in the coming year, it would begin disclosing the fees it pays to doctors for speaking arrangements and consulting work.

The interactions between pharmaceutical companies and the doctors who prescribe their drugs and help run their clinical trials have sometimes come under intense scrutiny. Critics have pointed out a potential conflict of interest in doctors prescribing drugs, then getting paid by those drugs' makers for one form of work or another....

Mi sembra una dimostrazione di trasparenza da parte della società! :yes:

Nel frattempo un altro farmaco sta per essere approvato in europa:

EU agency back's Eli Lilly's Zypadhera

LONDON, Sept. 25 (Reuters) - The European Medicines Agency has recommended Eli Lilly & Co.'s (LLY.N: Quote, Profile, Research, Stock Buzz) Zypadhera -- known generically as olanzapine pamoate -- for treatment of schizophrenia, the London-based watchdog said on Thursday.
Recommendations for marketing approval by the agency's Committee for Medicinal Products for Human Use (CHMP) are normally endorsed by the European Commission within a couple of months.
 
Pensavo che il Prasugrel fosse più importante visto che dovrebbe andare in concorrenza con il Plavix della Sanofi che ha grandi vendite.
Ma se vai alle conferenze mediche ne saprai certamente più di noi! :yes:

La mia idea era quella di entrare in zona 41-42$ e rivendere al prezzo obiettivo di 50$. Con l'eventuale approvazione del farmaco il target potrebbe cambiare; certo non è che mi aspetto salti mortali...

Ah, ma il Plavix sta' per diventare generico. O porta notevoli vantaggi in termini di riduzione degli effetti collaterali o restera' di nicchia. Senza poi parlare della banale cardioaspirina. Il Plavix necessita spesso in Eu di approvazione separata per il rimborso dalla mutua tra l'altro

Pensavo parlassi degli anticoagulanti per un momento. A volte seguo troppi congressi... :rolleyes:
 
Ah, ma il Plavix sta' per diventare generico. O porta notevoli vantaggi in termini di riduzione degli effetti collaterali o restera' di nicchia. Senza poi parlare della banale cardioaspirina. Il Plavix necessita spesso in Eu di approvazione separata per il rimborso dalla mutua tra l'altro
Pensavo parlassi degli anticoagulanti per un momento. A volte seguo troppi congressi... :rolleyes:

Non ho studiato medicina quindi non saprei andare nei dettagli:mmmm:, quello che dico rispetto a Prasugrel è quello che si legge nel giornali e su internet, tipo il trafiletto che ho riportato alla prima pagina del thread infondo.

Da lì ho preso le seguenti informazioni in modo logico: Prasugrel è un blood-thinner-> ovvero anti-coagulante-> Prasugrel va in concorrenza con il Plavix -> Plavix è un medicinale da 8 milliardi $ di fatturato l'anno -> Se viene approvato diventa importante per Eli Lilly.

Resto nel mio orticello, non è che vengo a dire a te che sei del settore come funzionano le medicine. Di teste calde ne è già pieno il FOL! :D
 
Non ho studiato medicina quindi non saprei andare nei dettagli:mmmm:, quello che dico rispetto a Prasugrel è quello che si legge nel giornali e su internet, tipo il trafiletto che ho riportato alla prima pagina del thread infondo.

Da lì ho preso le seguenti informazioni in modo logico: Prasugrel è un blood-thinner-> ovvero anti-coagulante-> Prasugrel va in concorrenza con il Plavix -> Plavix è un medicinale da 8 milliardi $ di fatturato l'anno -> Se viene approvato diventa importante per Eli Lilly.

Resto nel mio orticello, non è che vengo a dire a te che sei del settore come funzionano le medicine. Di teste calde ne è già pieno il FOL! :D


Caro Seven.... :bow: Lungi da me' l'idea di fare il "saputello" solo perche' seguo i congressi medici per lavoro....;)

Quello che intendevo dire e' che il brevetto per il Plavix scade negli USA nel 2011 e in Europa nel 2013 (Source: Sanofi). Se la Lilly lancia nel 2009 hanno meno di 3 anni prima di dover competere con un Plavix a basso costo senza contare che ci sono altre societa' che hanno sviluppato versioni copia come questa per esempio...

Basle, Switzerland - Cimex AG, a Swiss-based specialty generics group, has announced that it has now received approval for a generic version of clopidogrel in Germany. It said that two marketing partners are expected to launch the generic product in Germany. These have previously been announced as Sandoz and Ratiopharm. No launch date has yet been revealed.

Cimex is a subsidiary of the Swiss company Schweizerhall, which says it is also expecting to obtain approval for the generic clopidogrel in Luxembourg within the second quarter of 2008, and applications for approval in additional European countries are in preparation. The European market for clopidogrel is currently about CHF 3.2 billion (€2 billion, $3.09 billion), of which Germany accounts for CHF 600 million, it reports.
 
...

Basle, Switzerland - Cimex AG, a Swiss-based specialty generics group, has announced that it has now received approval for a generic version of clopidogrel in Germany. It said that two marketing partners are expected to launch the generic product in Germany. These have previously been announced as Sandoz and Ratiopharm. No launch date has yet been revealed.
...

Cerca e ri-cerca ho trovato che Cimex e' adesso "Acino" e a Zurigo scambia oggi cosi': :eek:

Last Trade/Volume CHF 220.00 / 8
Daily Change -0.90%
Date/Time 26.09.2008 / 17:31
Market Closed
Previous Close 222.00
Open 223.50
Bid 650, 219.00
Ask 60, 220.00

Almeno mi sembra di avere capito che dal 1° settembre fa' parte di "Acino" ma a quanto vedo ha volume = 8 :confused:
Chiedo lumi... magari non ho capito una mazza... :mmmm:
 
:wall::wall::wall::wall::wall::wall:

INDIANAPOLIS (AP) — Federal health regulators delayed a decision on a blood thinner from Eli Lilly for a second time Friday, raising concerns on Wall Street about the potential blockbuster medication.

The drug is considered crucial to Indianapolis-based Lilly, which faces a wave of patent expirations in the next few years.

Lilly said in a statement the Food and Drug Administration has still not completed its review of the drug, which was submitted in January. Agency scientists already delayed a decision on June, saying they needed more time.

"This is a very large, complex submission, and it should not be surprising that delays occur," said Jennifer Stotka, a vice president with Lilly in a statement. The company said it would not speculate on the cause of the delay.

Indianapolis-based Lilly developed the drug with Japanese drugmaker Daiichi Sankyo Co. It is designed to treat patients with acute coronary syndromes such as heart attacks or unstable angina who are at risk of developing blood clots.

The drug's approval is key for Lilly's financial outlook, as it faces looming patent expirations. The patent on its best-selling drug, the anti-psychotic Zyprexa, is due to expire in 2011. Zyprexa contributed more than a quarter of the company's $18.6 billion in sales last year.

Analysts say prasugrel could bring in anywhere from $600 million to $1 billion in revenue.

UBS analyst Roopesh Patel said it was hard to draw conclusions from Lilly's statement because it simply says the FDA had not completed its review.

"Based on this, one can't necessarily conclude as to whether or not the final outcome would be positive or negative," Patel said.

He thinks Lilly will have to wait weeks or maybe months to hear more from the FDA.

"You're not talking about two or three years before the FDA comes back with an answer," he said.

A delay that long, or a request for more trials could be just as bad as a rejection. Plavix also loses patent protection in 2011, and analysts say prasugrel would need time to establish itself in the market before facing generic competition.

The blockbuster Plavix, made by Sanofi-Aventis SA and Bristol-Myers Squibb Co., was the second-best-selling prescription medicine in the world last year with sales of $7.3 billion, according to pharmaceutical data provider IMS Health.

Bristol-Myers executives have said they consider prasugrel a niche drug that targets only a small percentage of Plavix patients. Plavix will lose patent protection in 2011, possibly opening the market to generic competition.

A head-to-head study released last year showed that fewer patients taking prasugrel developed blood clots in stents or suffered heart attacks, strokes or heart-related deaths when compared with those taking Plavix.

However, the study also showed that major bleeding occurred in a higher percentage of patients taking prasugrel.

Shares of Eli Lilly fell $1.82, or 3.9 percent, Friday to $46.82 in after-hours trading.

:wall:
 
Comunicato chiaramente il venerdi' sera (23.10 ora ita) a mercato chiuso :mad:
 
Rimandata! I falchi opportunisti escono dal titolo, ci può stare. Riporto anche questo articolo, così combinando le notizie si hanno più informazioni:

Federal regulators delay decision on Eli Lilly blood thinner prasugrel for second time

INDIANAPOLIS - Federal health regulators delayed a decision on a blood thinner from Eli Lilly for a second time Friday, raising concerns on Wall Street about the potential blockbuster medication.

The drug, called prasugrel, is considered crucial to Indianapolis-based Lilly, which faces a wave of patent expirations in the next few years.

Lilly said in a statement the Food and Drug Administration has still not completed its review of the drug, which was submitted in January. Agency scientists already delayed a decision on June, saying they needed more time.

"This is a very large, complex submission, and it should not be surprising that delays occur," Jennifer Stotka, a vice president with Lilly, said in a statement. The company said it would not speculate on the cause of the delay.

Lilly developed the drug with Japanese drugmaker Daiichi Sankyo Co. Prasugrel is designed to treat patients with acute heart problems such as heart attacks or unstable angina who are at risk of developing blood clots.

The drug's approval is key for Lilly's financial outlook, as the patent on its best-selling drug, the anti-psychotic Zyprexa, is due to expire in 2011. Zyprexa contributed more than a quarter of the company's $18.6 billion in sales last year.

Analysts said prasugrel could bring in anywhere from $600 million to $1 billion in revenue.

UBS analyst Roopesh Patel said it was hard to draw conclusions from Lilly's statement because it simply said the FDA had not completed its review.

"Based on this, one can't necessarily conclude as to whether or not the final outcome would be positive or negative," Patel said.

He thinks Lilly will have to wait weeks or maybe months to hear more from the FDA.

"You're not talking about two or three years before the FDA comes back with an answer," he said.

A delay that long, or a request for more trials could be just as bad as a rejection.

Prasugrel would compete against the blockbuster blood thinner Plavix, which loses patent protection in 2011. Analysts say prasugrel needs time to establish itself in the market before facing generic versions of Plavix, which will sell for a fraction of that drug's original price.

Plavix, made by Sanofi-Aventis SA and Bristol-Myers Squibb Co., was the second-best-selling prescription medicine in the world last year, with sales of $7.3 billion, according to pharmaceutical data provider IMS Health.

Bristol-Myers executives have said they consider prasugrel a niche drug that targets only a small percentage of Plavix patients.

A head-to-head study released last year showed that fewer patients taking prasugrel developed blood clots in stents or suffered heart attacks, strokes or heart-related deaths when compared with patients taking Plavix.

However, the study also showed that major bleeding occurred in a higher percentage of patients taking prasugrel.

Shares of Eli Lilly fell $1.91, or 4 percent, Friday to $44.91 in after-hours trading.
 
:mmmm: mi pare uguale alla mia...
 
:o

Twenty-nine years ago, I came to Indianapolis fresh out of graduate school to become a bench chemist at Eli Lilly and Co. Six months ago, Lilly gave me the honor and the responsibility of a lifetime by promoting me to chief executive officer. I have come to know the importance of innovation, and under my leadership in the days ahead, Lilly will have no greater priority.

Innovation is not change for the sake of change. Instead, true innovation responds to deficiencies and problems in what already exists. Innovation starts with an insight and builds to an answer.
Advertisement

At Lilly, we see three major "deficiencies and problems" that affect the health of patients and that of our business.

» For many reasons, individual patients too often fail to realize the full benefit of new medicines. There are many miracles, to be sure, but they co-exist with too many disappointments and outright failures.

» The pace of breakthroughs is too slow and the costs are too high. Our industry averages of 12 years and $1.3 billion to bring a new drug to market are not good enough.

» Obscured benefits and costly, delayed breakthroughs mean that our value proposition is not what it should be, which in turn drags down the returns we can deliver to our shareholders.

This analysis points straight to our marching orders. Lilly's strategy is to create value for our shareholders by accelerating the flow of innovative new medicines that provide improved outcomes for individual patients.

Tremendous advances in genomics and other basic research; the unleashing of talent in places such as China, India and eastern Europe; and our society's broader efforts to manage the enormous costs of chronic disease and human aging -- all of this combines to make Lilly's strategy timely, attainable and, in my view, very exciting.

So we are moving quickly to transform Lilly through five broad areas of activity. In our labs and clinics, we aim now to produce "tailored therapies." These are products with vast amounts of embedded knowledge about the types of patients who will benefit -- at which stage of a disease, at which dosages, and in combination with which other treatments and lifestyle changes.

Tailoring, as we call it, also changes how we work with doctors and patients. For example, our sales representatives are moving away from dispensing reminder items and 30-second speeches and toward a more personalized, collaborative approach with doctors and their teams.

Lilly also will move more aggressively into biotechnology, a wellspring of tailored therapies. We are already among the world's top biotech companies as measured by sales. But we have only begun to exploit our competitive advantages in bringing such innovation to patients, including our deep medical knowledge, coupled with our expertise in biotech research and development and complementary expertise in chemistry.

To speed development and control costs, Lilly is cutting layers of management to give our individual leaders more autonomy and control. We will continue to keep a tight rein on the size of our work force.

We also will expand Lilly's global scope and reach. This includes boosting our sales efforts in growth markets, but also building out a potentially game-changing, networked model of collaboration in all areas of the business.

Synthesis of Lilly chemical compounds by a firm in Shanghai; risk-sharing deals with companies in India to prove early-stage discoveries; inbound venture capital to speed up the development of high-risk Alzheimer's treatments; outbound venture capital in biotech start-ups, and a shift of responsibility for materials management to a partner down the road in Bloomington -- all of these moves, and many more, are tied together by the insight that Lilly need not and should not "own" capabilities that others can do better, or at less cost.

Finally, Lilly will be vigilant for opportunities to diversify -- not by moving into unrelated businesses but by venturing into new therapeutic areas; exploring the convergence of pharmaceuticals, medical devices, and diagnostic tools to improve "tailoring;" and certainly by growing our well-positioned Elanco animal-health subsidiary.

Some things will not change. Indianapolis will remain Lilly's headquarters and our R&D nerve center. We will be active and generous corporate citizens. We will create jobs, though more often with partners than through our own employment rolls.

Make no mistake: We are not your grandfather's Lilly. We can't be.

Instead, we have embarked on a transformation, the likes of which our company has never experienced. We are doing this to strengthen our ability to innovate so that we can deliver value to our shareholders, remain a vital part of Indiana's economy, and contribute in a major way to human health in the 21st century.
• Lechleiter is president and CEO of Eli Lilly and Co.

... un po' come dire agli investitori, non abbandonatemi? :confused:
 
Ancora sulla ultima news...

Eli Lilly (LLY) and Daiichi Sankyo [Tokyo: 4568] announced on Friday evening that the FDA had not completed the regulatory review for their blood thinner drug, which would go by the brand name of Effient [prasugrel].

The FDA previously delayed its decision by three months earlier this summer, but in this case no new deadline was set by the agency. Shares of Eli Lilly slid by about 4% after hours on less than 100,000 shares traded, closing near its 52-week low at $45.01 per share on Friday evening (click to enlarge chart, above). However, the current slide in shares of Eli Lilly could prove to be a good entry point assuming the issues surrounding the delay are minor or just caused by the FDA being understaffed.

Analysts are forecasting blockbuster sales for Effient, which could eventually reach $2 billion by some estimates; so approval for the drug is important to fuel the future growth of Eli Lilly in the face of looming generic competition for Zyprexa.

Effient would represent new competition for the multi-billion dollar blood thinner Plavix, which is marketed by Bristol-Myers (BMY) and Sanofi-Aventis (SNY). Given the complexity of the regulatory filing for Effient and the previous three month delay, it appears the FDA probably just needs more time to review the application rather than something more ominous such as requiring additional clinical trials. Also, many companies have faced similar delays by the agency, such as Cardiome's (CRME) wait of over six months for an approvable ruling on Kynapid.

:specchio:
 
Ultima modifica:
FDA probably just needs more time to review the application rather than something more ominous such as requiring additional clinical trials. Also, many companies have faced similar delays by the agency, such as Cardiome's (CRME) wait of over six months for an approvable ruling on Kynapid.

6 mesi sono davvero tanti!:eek:
Speriamo che le fondi ufficiali riducano l'attesa, altrimenti il titolo si potrebbe fare un -10% di discesa diluito nel tempo.
 
Un po' di ossigeno... :clap:

First-Line Chemotherapy Regimen Showed Clinically Relevant Survival Differences in Specific Histology Types of Advanced Non-Small Cell Lung Cancer INDIANAPOLIS, Sept. 29


INDIANAPOLIS, Sept. 29 /PRNewswire-FirstCall/ -- Eli Lilly and Company
(NYSE: LLY) announced today it received approval from the U.S. Food and Drug
Administration (FDA) for the use of ALIMTA(R) (pemetrexed for injection), in
combination with cisplatin, in the first-line treatment of locally-advanced
and metastatic non-small cell lung cancer (NSCLC), for patients with
nonsquamous histology.
ALIMTA is not indicated for treatment of patients with
squamous cell non-small cell lung cancer. NSCLC is the most common form of
lung cancer, resulting in more than 180,000 new cases in the U.S. each
year.(1,2)


NSCLC is defined as a group of histologies, that is, tumor types
differentiated by cellular structure. Nonsquamous histology includes
adenocarcinoma, large cell carcinoma and all other histologies except squamous
cell carcinoma.


This marks the third U.S. indication for ALIMTA. In 2004, ALIMTA received
consecutive approvals: first in combination with cisplatin as a treatment for
patients with malignant pleural mesothelioma, whose disease is unresectable or
who are otherwise not candidates for curative surgery, and then as a single
agent for the second-line treatment of patients with locally-advanced or
metastatic NSCLC after prior chemotherapy treatment.(3)


The ALIMTA approval in first-line advanced NSCLC for nonsquamous cell
histology is based on a Phase III, open-label randomized study (1725 patients)
that evaluated ALIMTA plus cisplatin (AC arm) versus GEMZAR(R) (gemcitabine
HCl for injection) plus cisplatin (GC arm). The median survival was 10.3
months in the AC arm and 10.3 months in the GC arm [adjusted hazard ratio 0.94
(95% CI: 0.84, 1.05)]. The median progression-free survival was 4.8 and 5.1
months for the AC and GC arms, respectively [adjusted hazard ratio 1.04 (95%
CI: 0.94, 1.15)]. The overall response rates were 27.1% and 24.7% for the AC
and GC arms, respectively.


In a pre-specified analysis, the impact of NSCLC histology on overall
survival was examined. Clinically relevant differences in survival according
to histology were observed. In the nonsquamous cell NSCLC subgroup, the median
survival was 11.0 and 10.1 months in the AC and GC groups, respectively
[unadjusted hazard ratio 0.84 (95% CI: 0.74, 0.96)]. However, in the squamous
cell histology subgroup, the median survival was 9.4 versus 10.8 months in the
AC and GC groups, respectively [unadjusted hazard ratio 1.22 (95% CI: 0.99,
1.50)].(4) This unfavorable effect on overall survival associated with
squamous cell histology observed with pemetrexed was also noted in a
retrospective analysis of the single-agent trial of pemetrexed versus
docetaxel in patients with stage III/IV NSCLC after prior chemotherapy.(5)


Patients treated with the ALIMTA regimen had less hematologic toxicity,
fewer blood transfusions and decreased use of growth factors compared to those
treated with the GEMZAR regimen. The most common adverse reactions (incidence
greater than or equal to 20%) for ALIMTA in combination with cisplatin
included vomiting, neutropenia, leukopenia, anemia, stomatitis/pharyngitis,
thrombocytopenia and constipation.


Based on the same data, the FDA also approved a change to the second-line
indication. ALIMTA is indicated as a single agent for the treatment of
patients with locally-advanced or metastic nonsquamous non-small cell lung
cancer after prior chemotherapy. ALIMTA is not indicated for treatment of
patients with squamous cell non-small cell lung cancer.


For full prescribing and safety information about ALIMTA, visit
www.ALIMTA.com.



Notes to Editor



About Non-Small Cell Lung Cancer (NSCLC)


NSCLC is the most common type of lung cancer and represents 85 to 90
percent of all lung cancers.(6) NSCLC has five-tier staging, starting at 0
and rising to the severity of stage IV.(7) NSCLC can spread through the
lymphatic system, penetrating the chest lining, ribs, and the nerves and blood
vessels that lead to the arm. The liver, bones and brain are potential
targets if the cancerous cells enter the bloodstream.


According to the World Health Organization (WHO) Cancer Report, lung
cancer is the world's most common cancer and the leading cause of cancer death
for men and women. More than 1 million people die from lung cancer each
year.(8)


NSCLC is defined as a group of histologies, that is, tumor types
differentiated by cellular structure. The most common NSCLC histology types
are squamous carcinoma, adenocarcinoma and large cell carcinoma.(9)



About Lilly Oncology, a Division of Eli Lilly and Company


For more than four decades, Lilly Oncology has been dedicated to
delivering innovative solutions that improve the care of people living with
cancer. Because no two cancer patients are alike, Lilly Oncology is committed
to developing novel treatment approaches. Our quest is to develop a broad
portfolio of tailored therapies that accelerate the pace and progress of
cancer care. To learn more about Lilly's commitment to cancer, please visit
www.LillyOncology.com.



About Eli Lilly and Company


Lilly, a leading innovation-driven corporation, is developing a growing
portfolio of first-in-class and best-in-class pharmaceutical products by
applying the latest research from its own worldwide laboratories and from
collaborations with eminent scientific organizations. Headquartered in
Indianapolis, Ind., Lilly provides answers -- through medicines and
information -- for some of the world's most urgent medical needs.


P-LLY

ALIMTA(R) (pemetrexed for injection), Lilly
GEMZAR(R) (gemcitabine HCl for injection), Lilly



This press release contains forward-looking statements about the potential
of ALIMTA and GEMZAR for the treatment of non-small cell lung cancer and
reflects Lilly's current beliefs. However, as with any pharmaceutical product
under development, there are substantial risks and uncertainties in the
process of development, commercialization, and regulatory review. There is no
guarantee that the products will receive additional regulatory approvals.
There is also no guarantee that the products will continue to be commercially
successful. For further discussion of these and other risks and
uncertainties, see Lilly's filings with the United States Securities and
Exchange Commission. Lilly undertakes no duty to update forward-looking
statements.



Important Safety Information for ALIMTA


ALIMTA is approved by the FDA in combination with cisplatin (another
chemotherapy drug) for the initial treatment of advanced nonsquamous non-small
cell lung cancer (NSCLC), a specific type of NSCLC. ALIMTA is not indicated
for patients who have a different type of NSCLC called squamous cell.


ALIMTA is approved by the FDA as a single agent (used alone) for the
treatment of patients with advanced nonsquamous non-small cell lung cancer
(NSCLC), a specific type of NSCLC, after prior chemotherapy. ALIMTA is not
indicated for patients who have a different type of NSCLC called squamous
cell.


ALIMTA is a treatment for Malignant Pleural Mesothelioma (MPM), which is a
cancer that affects the inside lining of the chest cavity. ALIMTA is given
with cisplatin, another anti-cancer medicine (chemotherapy) when surgery is
not an option.



Myelosuppression is usually the dose-limiting toxicity with ALIMTA
therapy.


ALIMTA may not be appropriate for some patients. If you are allergic to
ALIMTA, tell your doctor because you should not receive it. If you think you
are pregnant, are planning to be pregnant, or are nursing, please tell your
healthcare team. ALIMTA may harm your unborn or nursing baby. Your physician
may advise you to use effective contraception (birth control) to prevent
pregnancy while you are being treated with ALIMTA.


If you have liver or kidney problems, be sure to tell your doctor. Your
dose of ALIMTA may have to be changed, or ALIMTA may not be right for you.
There is a risk of side effects associated with ALIMTA therapy. ALIMTA can
suppress bone marrow function. It is very important to take folic acid and
vitamin B12 prior to and during your treatment with ALIMTA to lower your
chances of harmful side effects.


Your healthcare professional will prescribe a medicine called a
corticosteroid, which lowers your chances of getting skin reactions with
ALIMTA. Ask your healthcare professional before taking medicines called NSAIDs
(nonsteroidal anti-inflammatory drugs used to treat pain or swelling). Tell
your doctor if you are taking other medicines, including prescription and
non-prescription medicines, vitamins, and herbal supplements.


The most common side effects of ALIMTA when given alone or in combination
with cisplatin, another chemotherapy drug, are low blood cell counts (red
blood cells, white blood cells, and platelets); tiredness; stomach upset,
including nausea, vomiting, and diarrhea; mouth, throat, or lip sores; loss of
appetite; rash; and constipation.


Call your healthcare professional right away if you have a fever, chills,
diarrhea, or mouth sores. These symptoms could mean you have an infection.
These are not all of the side effects of ALIMTA. If you have any side effect
that bothers you or that doesn't go away, be sure to talk with your healthcare
professional.


You will have regular blood tests before and during your treatment with
ALIMTA. Your doctor may adjust your dose of ALIMTA or delay your treatment
based on the results of your blood test and on your general condition.


For more information about all of the side effects of ALIMTA, please talk
with your healthcare team, see the complete Prescribing Information at
www.ALIMTA.com, or call 1-800-545-5979.



Important Safety Information for GEMZAR


GEMZAR is indicated in combination with cisplatin (another type of
chemotherapy) for the first-line treatment of patients with locally advanced
(stage IIIA or stage IIIB) or metastatic (stage IV or cancer that has spread)
non-small cell lung cancer for whom surgery is not possible.



Myelosuppression is usually the dose-limiting toxicity with GEMZAR
therapy.


GEMZAR may not be appropriate for some patients. If you are allergic to
GEMZAR, tell your doctor you should not receive it. GEMZAR can suppress bone
marrow function. There have been rare reports of serious kidney or liver
toxicity with GEMZAR treatment, sometimes fatal. Serious lung toxicity has
also been reported, sometimes fatal. If you think you are pregnant, are
planning to be pregnant, or are nursing, please tell your healthcare team.
GEMZAR may harm your unborn or nursing baby.


If you have had prior kidney or liver problems or impairment, please tell
your healthcare professional. GEMZAR may not be right for you. GEMZAR has not
been shown to work in children. Tell your doctor if you are taking other
medicines, including prescription and non-prescription medicines, vitamins, or
herbal supplements.


There is a risk of side effects associated with GEMZAR therapy. The most
common side effects are low blood cell counts (red blood cells, white blood
cells, and platelets); fever; infection; hair loss; tiredness; nausea,
vomiting, constipation, and diarrhea; rash; shortness of breath; muscle aches;
and numbness or tingling in your toes or fingers. These are not all of the
side effects of GEMZAR. If you have any side effect that bothers you or that
doesn't go away, be sure to talk with your healthcare professional. Call your
healthcare professional right away if you have fever or chills. These symptoms
could mean you have an infection.


You will have regular blood tests before and during your treatment with
GEMZAR. Your doctor may adjust your dose of GEMZAR or delay your treatment
based on the results of your blood test and on your general condition.


For more information about all of the side effects of GEMZAR, please talk
with your healthcare team, see the complete Prescribing Information at
www.GEMZAR.com, or call 1-800-545-5979.


You are encouraged to report negative side effects of prescription drugs
to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.



(1) American Cancer Society, "What Is Non-Small Cell Lung Cancer?,"
October 15, 2007, American Cancer Society,
http://www.cancer.org/docroot/CRI/content/CRI_2_4_1x_What_Is_Non-
Small_Cell_Lung_Cancer.asp?rnav=cri, (February 21, 2008).


(2) American Cancer Society, "What Are the Key Statistics About Lung
Cancer?," October 15, 2007, American Cancer Society,
http://www.cancer.org/docroot/CRI/content/CRI_2_4_1x_What_Are_the_Key_Statisti
cs_About_Lung_Cancer_15.asp?rnav=cri, (September 19, 2008).


(3) NOTE: The 2nd-line NSCLC indication was approved under 21 CFR 314.500
et seq (Subpart H - Accelerated Approval of New Drugs for Serious or
Life-Threatening Illnesses) using a surrogate endpoint.


(4) Scagliotti G, Vittorio P, et al. Phase III Study Comparing Cisplatin
Plus Gemcitabine With Cisplatin Plus Pemetrexed in Chemotherapy-Naive Patients
With Advanced-Stage Non-Small-Cell Lung Cancer; J Clin Oncol 2008 26: 3543-
3551.


(5) Peterson P, Park K, et al. Is pemetrexed more effective in patients
with non-squamous histology? A retrospective analysis of a phase III trial of
pemetrexed vs docetaxel in previously treated patients with advanced nonsmall
cell lung cancer (NSCLC). Abstract P#6521, The European Cancer Conference 2007
(ECCO 14). European Journal of Cancer Supplements, Vol 5 No 4, Page 363.


(6) American Cancer Society, "What Is Non-Small Cell Lung Cancer?,"
October 15, 2007, American Cancer Society,
http://www.cancer.org/docroot/CRI/content/CRI_2_4_1x_What_Is_Non-
Small_Cell_Lung_Cancer.asp?rnav=cri, (February 21, 2008).


(7) American Cancer Society, "How Is Non-Small Cell Lung Cancer Staged?"
October 15, 2007, American Cancer Society,
www.cancer.org/docroot/CRI/content/CRI_2_4_3x_How_Is_Non-
Small_Cell_Lung_Cancer_Staged.asp?rnav=cri, (February 21, 2008).


(8) World Health Organization, Gender in Lung Cancer and Smoking
Research, Department of Gender, Women and Health, 2003,
http://www.who.int/gender/documents/en/lungcancerlow.pdf.


(9) National Cancer Institute, "Non-Small Cell Lung Cancer Treatment
(PDQ(R)) Health Professional Version," December 14, 2007, National Cancer
Institute, www.cancer.gov/cancertopics/pdq/treatment/non-small-cell-
lung/HealthProfessional/page2, (February 14, 2008).



(Logo: http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO )



SOURCE Eli Lilly and Company
 
Unico titolo su una trentina che controllo che resta a -1.5 :wall::wall::wall:
Come mai..... :confused::confused::confused:
 
Indietro