Replies to post #43582 on Biotech Values

[JamaicaBaby]

Press Release Source: Vical Incorporated


Vical Announces Licensee's Conditional Approval of Therapeutic Cancer Vaccine for Dogs
Monday March 26, 12:30 pm ET


SAN DIEGO, March 26 /PRNewswire-FirstCall/ -- Vical Incorporated (Nasdaq: VICL - News) today announced that its licensee Merial Limited, a joint venture of Merck & Co., Inc. and sanofi-aventis, received notification of conditional approval from the U.S. Department of Agriculture (USDA) to market a therapeutic DNA vaccine designed to treat melanoma, a serious form of cancer, in dogs. The approval triggers a $0.2 million milestone payment to Vical. "Conditional approval" means the product has been shown to be safe and have a reasonable expectation of efficacy in treating melanoma. The designation allows Merial to market the therapeutic vaccine while collecting additional efficacy data to support full marketing approval.

"This canine melanoma therapeutic DNA vaccine is the first companion animal product to receive conditional approval for our licensee Merial," said Vijay B. Samant, Vical's President and Chief Executive Officer, "which represents a significant advancement for our DNA delivery platform technology, building on the previous approval of a vaccine for farm-raised salmon for another of our licensees. Through our independent and partnered programs, we continue advancing toward initial approvals of DNA-based human health products for infectious diseases, cancer, and angiogenesis. We believe the progress of this DNA-based therapeutic vaccine for canine melanoma bodes well for DNA- based approaches for human melanoma. We are particularly encouraged by the prospects for our Allovectin-7® DNA-based immunotherapeutic for patients with metastatic melanoma."

About Canine Melanoma

Melanoma is an aggressive form of cancer that commonly occurs in the dog's mouth, toes or footpads, and is virtually always malignant at these sites. Normal treatment for canine melanoma includes surgery, radiation, and combination chemotherapy, but even after successful treatment, the melanoma often recurs. Merial's melanoma therapeutic DNA vaccine is designed as an adjunct to treat melanoma in dogs.

About Vical

Vical researches and develops biopharmaceutical products based on its patented DNA delivery technologies for the prevention and treatment of serious or life-threatening diseases. Potential applications of the company's DNA delivery technology include DNA vaccines for infectious diseases or cancer, in which the expressed protein is an immunogen; cancer immunotherapeutics, in which the expressed protein is an immune system stimulant; and cardiovascular therapies, in which the expressed protein is an angiogenic growth factor. The company is developing certain infectious disease vaccines and cancer therapeutics internally. In addition, the company collaborates with major pharmaceutical companies and biotechnology companies that give it access to complementary technologies or greater resources. These strategic partnerships provide the company with mutually beneficial opportunities to expand its product pipeline and address significant unmet medical needs. Additional information on Vical is available at www.vical.com.

This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements about Merial's melanoma therapeutic DNA vaccine, Vical's technology and its current and potential applications, as well as the company's focus, collaborative partners, and product candidates. Risks and uncertainties include whether Merial will successfully market and distribute its melanoma therapeutic DNA vaccine, and if so, to what extent; whether Merial's melanoma therapeutic DNA vaccine will be a successful adjunct treatment for melanoma in dogs; whether Merial will collect sufficient additional efficacy data on its melanoma therapeutic DNA vaccine to support full marketing approval; whether Vical's Allovectin-7® or any other product candidates under development by Vical or its collaborative partners will be shown to be safe and effective in clinical trials; the timing, nature and cost of clinical trials; whether Vical or its collaborative partners will seek or gain approval to market any product candidates; whether Vical or its collaborative partners will succeed in marketing any product candidates; and additional risks set forth in the company's filings with the Securities and Exchange Commission. These forward- looking statements represent the company's judgment as of the date of this release. The company disclaims, however, any intent or obligation to update these forward-looking statements.


Contacts: Investors: Media:
Alan R. Engbring Susan Neath
Vical Incorporated Porter Novelli Life Sciences
[phone] [phone]
Website: www.vical.com




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[DewDiligence]

New Clot Drugs Beckon as Replacements for Warfarin

[This article is an overview of the competitive landscape in next-generation anticoagulants. Among the players are BAY, BMY, LLY, and Boehringer. This makes a good companion piece with the recent WSJ overview of the antiplatelet arena (#msg-18197555).]

http://yahoo.reuters.com/news/articlehybrid.aspx?type=comktNews&storyID=urn:newsml:reuters.com:2...

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By Ransdell Pierson

NEW YORK, April 13 (Reuters) - A new crop of medicines to prevent stroke and blood clots could emerge within several years, easing dangers and hardships for patients and creating blockbuster sales for drugmakers.

The oral drugs could prove better and safer than injectable medicines such as heparin now widely used to cut the risk of dangerous blood clots in the legs and lungs after major surgery.

But makers of the new drugs say their biggest use would be as an alternative to warfarin, a pill used for decades by people with atrial fibrillation -- or irregular heartbeat -- to prevent strokes. An estimated two million Americans have been diagnosed with the heartbeat problem and the number is expected to double in the next 20 years.

Warfarin, sold by Bristol-Myers Squibb Co. <BMY> under the brand name Coumadin but now widely available as a generic, is notoriously difficult to tolerate because of its interactions with food and other medicines.

Patients taking warfarin must undergo constant blood tests to ensure that warfarin levels are sufficient to prevent strokes, but not so high that they increase the risk of dangerous bleeding or brain hemorrhages. Moreover, patients scheduled for surgery must stop taking warfarin days ahead of time, to avoid serious bleeding.

"With all these disadvantages, an alternative to warfarin is direly needed, particularly since our aging population is becoming more vulnerable to atrial fibrillation and other conditions that can cause dangerous blood clots," said Dr. Stephen Winters, an associate professor of medicine at New Jersey Medical School.

"Replacement drugs for warfarin would be blockbusters because of the critical need," he said.

Among the replacement candidates, a once-daily pill called rivaroxaban , being developed jointly by Bayer AG <BAY> and Johnson & Johnson <JNJ>, is the farthest along in clinical trials and could fetch annual sales of more than $2.5 billion, analysts say.

Bayer aims in 2010 to seek approval to market the compound for stroke prevention related to atrial fibrillation. It plans later this year to unveil data from studies testing the drug's ability to prevent blood clots after orthopedic surgery, a less lucrative indication.

Like several rival pills under development, rivaroxaban blocks the Factor Xa protein, which plays an early role in the chemical process by which blood clots are formed.

"It potentially could replace Coumadin," said Frank Misselwitz, Bayer's head of cardiovascular clinical development.

Bayer has tested a wide range of doses and "has not had to stop any of them due to increased bleeding," a worrisome common side effect of Coumadin, heparin and other anti-clotting medicines, Misselwitz said. "And we've had good efficacy even at the lowest doses."

"Because of its predictability, unlike warfarin, you don't need monitoring, and the same dose is used despite gender and body weight," Misselwitz said.

Bristol-Myers' Factor Xa inhibitor, called apixaban , is believed to be just behind rivaroxaban in a similar range of late-stage trials.

Apixaban has reduced rates of death and clots in legs and lungs of patients that have undergone orthopedic surgery, compared with Lovenox, an improved form of heparin sold by Sanofi-Aventis <SNY>. Late-stage trials of apixaban began last year for prevention of strokes associated with atrial fibrillation.

"Clearly, for patients who are hard to maintain on warfarin because of dietary restrictions and interactions with other medicines, there could be clear advantages to switching" to newer drugs like apixaban, said Jack Lawrence, who leads the apixaban program for Bristol-Myers.

Lawrence said that apixaban will likely require two doses a day. That could give a marketing advantage to Bayer's rivaroxaban because "the first once-daily drug will gain the lion's share" of sales, Bayer's Misselwitz said.

The brokerage Cowen and Co. predicts an oral Factor Xa inhibitor being developed by Eli Lilly and Co. <LLY> could post annual sales of $600 million by 2012, based in part on its apparent equivalence to Lovenox in mid-stage trials to prevent dangerous clots among patients undergoing knee and hip replacements.

"It was safe and well tolerated and there was no difference in bleeding risk, which was the exciting thing," said Holger Ilske, a senior Lilly research executive. He said the drug, called LY517717 , has once-a-day potential, and Lilly is gearing up for Phase III stroke-prevention trials.

Researchers are placing high hopes on Factor Xa inhibitors following AstraZeneca's <AZN> decision last year to halt development of Exanta, a blood thinner once deemed a likely replacement for warfarin.

Exanta, which worked by directly blocking another clotting protein called thrombin, was scrapped due to concerns that it could harm the liver.

Privately held German drugmaker Boehringer Ingelheim is conducting late-stage trials of its own thrombin inhibitor, called dabigatran, to prevent blood clots following surgery.

Manfred Haehl, senior medical vice president of Boehringer, said the company "is substantially ahead of plan" in a stroke-prevention trial involving 15,000 patients with atrial fibrillation.

"If things continue well, we could also seek marketing approval ahead of plans, maybe by the end of 2009" for stroke prevention, he said.

Haehl said it remains unclear how long it will take his drug and the Factor Xa medicines to supplant warfarin, if they are approved.

"The more convincing the results are in terms of establishing better safety than warfarin, the faster it will happen. But with all these developments taking place, I think they will take over," he said.
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[DewDiligence]

Lilly Bets on Prasugrel

[A helpful companion read is #msg-18197555.]

http://online.wsj.com/article/SB118713994336698008.html

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By PETER LOFTUS
August 15, 2007

Eli Lilly & Co.'s long-term prognosis hinges on whether its experimental heart drug is better than a current blockbuster, and an answer is expected soon.

By early November, the Indianapolis pharmaceutical company hopes to release results of a large patient trial of prasugrel, the most important experimental drug in its pipeline. Prasugrel is a blood-thinning agent designed to prevent recurring heart attacks and strokes in people with cardiovascular disease.

The market opportunity is huge. The leading blood thinner, Plavix, generated nearly $6 billion in sales last year for its co-marketers, Sanofi-Aventis and Bristol-Myers Squibb Co. Lilly and its Japanese development partner, Daiichi Sankyo Co., hope their drug will prove superior to Plavix and -- if it receives regulatory approval -- begin to take away market share from Plavix.

"If prasugrel really is demonstrably better, it can get a major share of that business," said Stephen Laveson, an analyst with Becker Capital Management, a Portland, Ore., investment firm that owns Lilly shares. Wall Street analysts predict annual prasugrel sales could approach $4 billion.

Earlier studies have suggested prasugrel is more potent than Plavix in blocking blood-platelet activity, which is a mechanism that helps ward off heart attacks. The latest trial of nearly 14,000 patients in 30 countries will show whether that potency translates into a reduction in cardiovascular deaths, heart attacks and strokes in people undergoing a certain heart procedure.

But for a blood-thinning agent, potency could come at a cost: a side effect is bleeding. The latest trial must also show that the risk of serious bleeding with prasugrel isn't significantly worse than that for Plavix, if prasugrel is to gain regulatory approval and market acceptance.

"One of the questions is, 'What's the trade-off?' " said Christopher Granger, director of the cardiac-care unit at Duke University Medical Center. "How potent can we get before we go too far and have caused intolerable bleeding?"

Lilly executives have said an earlier study showed no statistically significant difference in overall bleeding rates between the drugs. Also, a committee of experts met periodically to monitor safety issues in the latest trial, and cleared it to run to completion.

Trial investigators are now examining data from the new Lilly-funded study, which began in 2004 and ended in July. Lilly hopes to present the data at a medical meeting in early November, but hasn't ruled out publicly disclosing preliminary results before then. If the data are positive, Lilly hopes to submit prasugrel for Food and Drug Administration approval by the end of this year. If the drug gets timely FDA approval, it could hit the market in 2008. Initially, the approved uses for prasugrel would be narrower than those for Plavix, but Lilly and Daiichi might seek additional approvals later.

Prasugrel is crucial to Lilly because its current best seller, the antipsychotic Zyprexa, is set to lose U.S. patent protection in 2011. Zyprexa generated more than one-fourth of Lilly's total revenue last year, or about $4.4 billion. Lilly needs another big seller on the market before much of Zyprexa's sales are lost to cheaper, generic competition. If prasugrel fails, Lilly's newer products and other experimental drugs may not be enough to fill the void.

Lilly has suggested it isn't overly dependent on prasugrel. "While it's a very important compound in late-stage development, it's not the only product in late-stage development," Chief Financial Officer Derica Rice said. He said the company is developing an inhaled form of insulin for diabetics, as well as an injectable form of Zyprexa. Still, the company has had pipeline setbacks, including a delay in regulatory approval of a drug for diabetic eye disease.

Investors seem to be taking a cautious approach in advance of the release of the new prasugrel data. "I don't think investors are making a big bet on it" ahead of the trial data, said Deutsche Bank analyst Barbara Ryan.

If successful, prasugrel would follow in the footsteps of Plavix and, before that, aspirin. All are known as antiplatelet agents, which work by blocking the formation of dangerous blood clots that lead to heart attacks and strokes. Studies have shown aspirin and Plavix reduce the risk of heart attacks and other cardiovascular events. Other companies are developing antiplatelet agents, including AstraZeneca PLC and Schering-Plough Corp. [#msg-18197555].

One limitation of Plavix is that its effect on blood platelets is variable, and some patients don't respond to it. Dr. Granger, the Duke cardiologist, said prasugrel appears to have a more consistent effect on platelets.

The effect of Plavix is predictable across the patient populations for which it is approved, said John Tsai, vice president of cardiovascular and metabolics research at Bristol-Myers. "It strikes a good balance between efficacy and safety," he said.

Dr. Granger thinks prasugrel needs to demonstrate at least a 15% reduction in risk of cardiovascular events compared with Plavix, if prasugrel is to be a success.

The prasugrel study has important implications for Bristol-Myers. The New York company recorded $3.3 billion in Plavix sales last year, or about 18% of its total revenue. Sales growth could slow if prasugrel reaches the market.

"We are taking prasugrel seriously, but we believe it will be focusing on a much smaller set of patients," Lamberto Andreotti, Bristol's chief operating officer of world-wide pharmaceuticals, told analysts on a conference call last month. He added that Bristol is waiting to see the late-stage prasugrel data before making a final assessment of how Plavix might be affected.
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[DewDiligence]

Because Plavix’s booked sales are split between SNY and BMY, some people may not realize how big a drug Plavix is. Worldwide 2009 sales were €6.78B, which comes to $9.3B* at the current exchange rate—despite the fact that Plavix is now available as a generic in such countries such as France and Germany.

http://finance.yahoo.com/news/Sanofiaventis-Delivers-prnews-1609646052.html?x=0&.v=1

*Lipitor is the only drug that has ever logged larger annual sales.