WSJ: FDA mapping new, faster path for cocktail drugs

The FDA has set its sights on a new and faster development pathway for drug cocktails, which could have a big impact on the therapeutic prospects for a slate of major diseases like cancer, AIDS, tuberculosis and hepatitis. And the Wall Street Journal reports that the initiative has helped inspire a major new development collaboration among pharma companies that will soon be announced. 

"This represents a bigger issue--the strengthening of regulatory science" to encompass scientific advances, FDA Commissioner Margaret Hamburg told the Wall Street Journal, which details the new initiative in an in-depth article today.

Up to now the agency has taken a one-drug-at-a-time approach, with developers going on to demonstrate how approved products can work better for some diseases when combined. Complex ailments like cancer often have to be fought on several fronts, making drug cocktails more successful than single therapies.

This new initiative could accelerate collaborations among developers, which can share costs and science and hope to benefit from a faster approval process--and which could add huge amounts of additional sales revenue from approved products. The WSJ also says that the billionaire software entrepreneur Bill Gates inspired a coalition of drug companies to agree to collaborate on new cocktail therapies for tuberculosis, an initiative that will be announced later today.

- here's the story from the Wall Street Journal

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Roche details pipeline strategy and its 10 leading programs

Roche has tipped investors on all the key talking points ahead of today's pipeline review. In a statement released early today, Roche noted that it is positioned to launch six new therapies by the end of 2014 and wants to push beyond cancer therapies and into new arenas, such as metabolism, inflammation and the central nervous system. And it has the potential to add 35 new indications for currently-approved therapies over four years.

Roche's scientists believe that the pipeline currently includes 10 new molecules with the potential to emerge as a best-in-class therapy. And the company says that it can move 20 programs into late-stage trials by 2015.

Among its top prospects, Bloomberg highlights: Taspoglutide, a new GLP-1 drug for Type 2 diabetes; Aleglitazar, also for diabetes; The ‘good cholesterol' drug dalcetrapib and PLX4032 for melanoma. All are believed to have solid blockbuster potential.

While Roche's income from oncology drugs failed to live up to expectations recently, its near-term revenue is pinned on three key blockbusters: Avastin, MabThera and Herceptin. Analysts also credit Roche with being in a far better position than most other Big Pharma outfits, with enough time to develop new products that can boost revenue ahead of any key patent losses. Today's pipeline show is designed to convince investors that it has that task well in hand.

- see this chart of Roche's late-stage pipeline
- here's the blow-by-blow from Roche
- read the Bloomberg story
- and here's the report from Reuters

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Biopharma R&D rises 2% in '09 despite recession

R&D investments by pharma and biotech companies in the U.S. actually rose two percent last year, according to a new report from PhRMA and Burrill & Co. And they pointedly note that that is a pretty good bottom line if you consider the savage recession that took a heavy toll on the overall economy. The R&D budget jumped to $65.3 billion in 2009, the analysts say. And the report adds that pharma companies devoted 18 percent of annual sales revenue into the development of new drugs--a point PhRMA repeatedly emphasizes to lawmakers interested in regulating the retail drug market. PhRMA release

Astellas tries board coup in hostile bid for OSI

Now that OSI's board has officially given Astellas the cold shoulder for its $3.5 billion takeover bid, the Japanese pharma company has nominated a slate of independent directors for the biotech who would give them a much warmer reception.

Astellas' nominees include some well-known biotech faces, including Aptuit founder Michael A. Griffith and Jill Kanin-Lovers, a veteran of the Alpharma board. They'll be expected to make the case that a combination of OSI and Astellas would help generate faster progress in the development of new cancer therapies.

OSI's major objection to the Astellas bid, of course, has nothing to do with R&D synergy. The OSI board has shunned Astellas' $52-a-share offer as far too low. And investors were quick to bid up the share price several dollars past that point in anticipation of a higher offer. To help nudge things along, OSI said yesterday that it is in talks with other potential buyers, including some unnamed Big Pharma players.

In a follow-up release, OSI said that it "believes the Astellas director nominees' only mandate is to support Astellas in acquiring OSI at an inadequate price."

- read the OSI release
- see Astellas' release
- here's the story from Bloomberg

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Unigene Labs raises $13.6M in debt restructuring

Boontoni, NJ-based Unigene Laboratories has restructured its debt, raising $13.6 million and giving Victory Park Capital Advisors, the sole investor in the transaction, the right to name two people to the company's board. Unigene also says that it has agreed to make changes to senior management. "This infusion of additional capital, coupled with the fact that we will not need to make interest payments on the notes until their maturity and that maturity date has been extended by approximately 18 months, will significantly improve our financial condition," said CEO Dr. Warren P. Levy. Unigene release

Roche pipeline close-up will focus on PhIII blockbusters

Roche investors are expected to pay particularly close attention at tomorrow's pipeline review day, when top execs for the pharma giant will try to put the best face possible on its new drug prospects.

This is the first pipeline review since Roche absorbed Genentech, and analysts will be looking to see whether the pharma giant's recent minor setbacks with programs like the rheumatoid arthritis drug ocrelizumab can be overshadowed by the promise presented by its new biotech arm and a slate of potential blockbusters. Unlike most of its Big Pharma competitors, Roche doesn't face a big patent cliff. And that has helped bolster its stock price. Now the analysts want to know how well positioned Roche is for the future.

"Investor expectations are high for this event and Roche does not have much margin for error, given the series of minor setbacks recently and the disappointment on 2009 sales," Natixis analysts said in a note.

The Genentech acquisition, though, is so recent that it's hard to see how Roche can blow it at this stage. Drug development is a notoriously slow process, and that gives Roche plenty of breathing space for completing the absorption process without much critical heat. So you can expect most of the attention to center on Roche's three late-stage blockbuster programs: dalcetrapib, aleglitazar and RG1678.

- here's the notice from Roche
- read the analysis from Reuters

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Cash squeeze triggers going-concern alert at Molecular Insight

A troubled Molecular Insight Pharmaceuticals (MIPI) needs to raise more cash to avoid breaching the minimum liquidity requirements tied to senior debt at the company, and that cash squeeze helped prompt its auditors to raise a going-concern warning for the second half of the year.

Auditors for the biotech are also concerned by recurring losses at the company, despite the smaller-than-expect quarterly loss reported yesterday evening. Investors in the company responded by driving down its stock price by about 25 percent in after-market trading.

Molecular Insight reported a $13.2 million loss for the fourth quarter and reported that it had about $64 million in cash and equivalents on hand at the end of 2009. On Monday the company reported that NASDAQ officials had notified them that they were in violation of its minimum market value requirement. And at the beginning of the year the developer said it cut nine employees to help reduce costs. Molecular Insight has two Phase III oncology trials slated to begin this year.

Molecular Insight says that it already out-licensed one program, Onalta, and has plans to out-license Zemiva, a late-stage radiopharmaceutical for the diagnosis of myocardial ischemia.

- check out Molecular Insight's release
- and here's the Reuters story

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Clark Johnson to become president, CEO of Neurologix

> Neurologix has tapped Vice Chairman Clark Johnson as its president and CEO to replace John Mordock, who has resigned. Release

> Bausch & Lomb has named Fred Hassan as chairman of the board of directors and Brent Saunders as CEO. Release

> MiddleBrook Pharmaceuticals CEO John Thievon has resigned, and CFO David Becker will become the acting CEO. Story

> Endo Pharmaceuticals has appointed Julie McHugh as the company's COO. Release

> Portola Pharmaceuticals has announced that President and CEO Charles Homcy will retire from his current position and assume the role of co-chairman of the board of directors. Chief Operating Officer William Lis will succeed Homcy as the new CEO. In addition, Hollings Renton has been appointed co-chairman and lead director of the board of directors. Release

> Genetix Pharmaceuticals has named Mitchell Finer as its chief scientific officer. Release

> Berndt Modig will become the CFO of Prosensa, the Dutch based biopharmaceutical company focusing on RNA modulating therapeutics. Release

> Timothy Barabe has been appointed CFO and EVP of Affymetrix. Release

> Caris Life Sciences has appointed Dan Sawyers as SVP, chief accounting officer and Greg Kelly, SVP of operations. Release

> San Diego's Organovo has named Marie Csete as EVP of R&D. Release

> OXiGENE has announced the resignation of Arthur Laffer from the company's board of directors to pursue other longstanding interests. Release

> James Sabry has resigned from the board of Cytokinetics to assume an operational role at pharmaceutical company. An announcement regarding his new role is expected soon. The Cytokinetics board has elected L. Patrick Gage as its chairman. Release

> Adeona has named Jeff Lucero Riley to its board of directors. Release

> Dutch biopharmaceutical company Crucell has announced the nominations of William Burns, James Shannon and George Siber to its supervisory board. Release

> Agios Pharmaceuticals has appointed William Kaelin, Jr. to its scientific advisory board. Release

> Shire has named Bill Burns to its board as a non-executive director. Burns has also been appointed a member of Shire's remuneration committee. Release

> A. Bruce Montgomery will join ZymoGenetics' board of directors. Release

> Russ Altman of the Stanford University Medical School has joined the NextBio's scientific advisory board. Release