FierceBiotech

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

John Carroll — Wed, 17 Mar 2010 11:17:17 -0400

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

John Carroll — Wed, 17 Mar 2010 11:09:26 -0400

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

Unigene Labs raises $13.6M in debt restructuring

John Carroll — Wed, 17 Mar 2010 10:53:26 -0400

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

John Carroll — Wed, 17 Mar 2010 10:46:32 -0400

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

Cash squeeze triggers going-concern alert at Molecular Insight

John Carroll — Wed, 17 Mar 2010 10:06:05 -0400

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

Clark Johnson to become president, CEO of Neurologix

Liz Jones — Wed, 17 Mar 2010 09:39:52 -0400

> 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

HGS investors shrug off a mid-stage cancer failure

John Carroll — Wed, 17 Mar 2010 09:29:32 -0400

Human Genome Sciences announced this morning that its cancer antibody flunked a mid-stage clinical trial, failing to produce better data on either disease response or progression-free survival for lung cancer when compared to a control group.

Mapatumumab is designed to trigger apoptosis, or cancer cell death, a popular strategy in the cancer field. The antibody binds to a protein known as TRAIL receptor 1 and HGS is also studying it for multiple myeloma and hepatocellular cancer. The biotech says it will have progression-free survival data available from the multiple myeloma study in mid-2010 and expects to initiate the randomization stage of the hepatocellular cancer study before the end of 2010. Today's release didn't include any specific data readouts, though. Those will be released at a scientific meeting sometime later in the year.

HGS' cancer program is its most advanced mid-stage product. But investors who have fueled a skyrocketing share price have been concentrating primarily on the far more promising prospect for Benlysta, which amazed the company's closest observers with unexpectedly positive late-stage lupus results last year. HGS also faces an October 4 PDUFA date for its hep C drug Zalbin. HGS shares slid only about one percent after the cancer news was announced.

- here's HGS's release

Novartis reports success with novel blood pressure drug

John Carroll — Wed, 17 Mar 2010 08:57:18 -0400

An experimental hypertension therapy in Novartis' pipeline has cleared an important mid-stage clinical trial hurdle and is headed for a pivotal test. Researchers for the pharma giant say that LCZ696--a combination of the experimental AHU377 with the standard drug Diovan-- significantly better than Diovan alone. And the combo therapy clearly outperformed a placebo.

LCZ696 is a new molecule created from the combination of AHU377 and Diovan. AHU377 is a new kind of drug similar to Bristol-Myers Squibb's omipatrilat, which was once thought to be a potential blockbuster before signs of dangerous side effects scuttled the program. This new therapy is designed to enhance the body's natural blood-pressure lowering machinery. The drug blocks angiotensin-2--which constricts blood vessels--while spurring a natural diuretic the body generates to help ease blood pressure.

In a study with 1,215 patients spread around 18 countries, the combo therapy performed almost twice as well as Diovan alone at a dose of 200 mg. And the rate of reduction in systolic levels fell in the same category as significant weight loss or a diet that concentrates heavily on fruit and vegetables.

"These findings build promise for this novel drug class. In addition, these study results demonstrate the potential for managing cardiovascular diseases through enhancement of the beneficial effects of the body's own natriuretic peptides via neprilysin inhibition and concomitant blockade of the angiotensin receptor," writes principal investigator Luis Ruilope. Significantly, patients taking the therapy had the same side effect profile as the placebo group. And if Novartis can successfully navigate Phase III, they may have a new standard of care in a huge market. Some 75 million American adults suffer from high blood pressure. But this is one field where safety issues can present enormous, and often unexpected, obstacles.

- see Novartis' release
- here's the WebMD story
- and here's the piece from Science News

BioTime soars on cell aging reversal

John Carroll — Tue, 16 Mar 2010 11:08:02 -0400

Shares of BioTime shot up over 33 percent this morning after investors got a whiff of a newly published scientific paper in which the biotech company says it was able to reverse the aging process in cells. And scientists for the company say the work has big implications for the development of a new generation of cell-based therapies that can target age-related degenerative diseases. Report

MannKind addresses Afrezza concerns following FDA response

Maureen Martino — Tue, 16 Mar 2010 11:00:24 -0400

In an analyst call this morning, MannKind discussed yesterday's complete response letter from the FDA for Afrezza, the company's inhaled insulin drug. The part of the response that sent tongues wagging yesterday was the FDA's request that the company submit available clinical data that support the "clinical utility" of Afrezza. Analysts and investors wondered whether the agency's wording meant that didn't see a need for another insulin product.

For MannKind, it comes down to a question of interpretation. "We interpret this request as a desire to understand the positioning of Afrezza within the range of available therapies, and a desire to know how, and in whom, and when in the course of therapy it should be used," CEO Alfred Mann said in the conference call. He emphasized that the agency asked for no additional studies and expressed no safety concerns about the drug.

The company also said that it believes its next-generation inhaler, known as "Dreamboat," will settle labeling question raised by the FDA. MannKind had planned to launch Afrezza with its existing MedTone devices and switch patients to the Dreamboat after securing a separate FDA OK for the product. Now the developer says it may submit an application for its new device in its response to the FDA's letter.

Mann said that his company is closer to a partnership deal now that it's received FDA feedback on the drug. According to the company, MannKind and an interested party were close to a deal for Afrezza last July, but uncertainties about the drug impacted valuation, making it pointless to close the deal until more agency guidance was received. "We were reluctant to partner until we had regulatory feedback because we couldn't determine the real value of Afrezza," Mann claimed. He added that the company's chances for a partnership are higher now that the list of outstanding items with Afrezza has been reduced to a few items.

MannKind has enough cash to make it into 2011. However, during the conference call, Mann said the company will work to reduce its spending over the next few weeks to move it farther into 2011. He didn't elaborate on how the developer plans to cut costs.

Mann seemed riled when asked whether the FDA had indicated whether the company would face an expert panel prior to the approval of Afrezza. "They've said very explicitly for almost a year now that we're not going to have a panel. Period." The bottom line? "We have no reason to believe that our plan to launch in 2011 will be adversely affected by the issues raise in the letter."