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Latest Biotech news

Amgen was buoyed by the news that new data demonstrates that motesanib slowed the progression of metastatic thyroid cancer. Out of 93 patients in the study, 49 had a positive response. Volunteers with a BRAF V600E mutation did better than those without the mutation. Report

FDA panel backs added risk review on diabetes drugs

A FDA advisory panel has voted 14-2 to recommend that the developers of diabetes drugs specifically demonstrate that their experimental therapies don't increase cardiovascular risks. And if as expected the agency follows the recommendation, developers in the diabetes field are looking at more complex trial demands that are likely to add significant cost to the trials process. The Wall Street Journal nominates AstraZeneca and Bristol-Myers Squibb as the first two biopharma companies to face the new standard. Their diabetes drug saxagliptin is headed to the FDA for a review.

- read the report in the Wall Street Journal

Three technologies that could change the world

The Financial Times has consulted the experts in drug discovery and settled on three new technologies that promise to transform patient care in years to come. Most FierceBiotech readers are already familiar with RNAi, where a number of companies are competing to advance new therapies. GWAS is second on the list; individual genetic variations that highlight a person's risk of disease. Finally the FT lists IPSCs, the pluripotent stem cells that act like embryonic stem cells. Big challenges have yet to be met in the field, but the experts say the long-term potential here is amazing.

- read the article in the Financial Times

P&G dumps development pact with ARYx

ARYx Therapeutics says that Procter & Gamble surprisingly dropped out of a pact to develop an experimental therapy for chronic constipation and dyspepsia. An AP report notes that ARYx had been scheduled to discuss data on ATI-7505 but canceled the presentation, explaining that it needed to discuss the data with P&G. Late last night ARYx said the therapy had successfully passed a safety study assessing cardiovascular risks. A mid-stage trial of the therapy is ongoing.

"We are surprised P&G would cancel our collaboration after receiving the results of the TQT (safety) study given that we achieved a successful result at the study's primary endpoint, and are disappointed in their decision to return the rights to ATI-7505 to us," said ARYx CEO Dr. Paul Goddard. "We have been informed by P&G their decision is based on their view of certain commercial and technical criteria, and that the program no longer fits into their future plans."

ARYx says the ongoing trial will be terminated but expects the therapy will return to the clinic once a new partner is found.

- see ARYx's release
- read the AP report

Shire to buy Jerini in $521M deal

With an eye toward snapping up a late-stage orphan drug for hereditary angiodema--a rare genetic disease--Shire has agreed to pay $521 million to acquire Berlin-based Jerini. That's a whopping 73 percent premium on Jerini's share price at Wednesday's close. Shire made it clear that it wants to add Firazyr to its portfolio. The therapy is expected to gain European approval later this year.

Jerini's other assets will undergo a "strategic review" following completion of the sale. Those other assets that may go on the sales block include Jerini Ophthalmic, a U.S. subsidiary working on wet age-related macular degeneration, and JPT Peptide Technologies GmbH, a manufacturing operation.

Annual sales of Firazyr are estimated at $350 million to $400 million a year. But Jerini has run into trouble with the FDA, which issued a non-approvable letter on the therapy. Shire, though, says it is confident that the agency's questions have been addressed.

"The proposed acquisition of Jerini would bring to Shire a new drug that is highly complementary to our HGT portfolio," says Shire CEO Angus Russell (photo). "Consistent with our strategy, Firazyr is a product which satisfies a high unmet medical need and treats a morbidly symptomatic disorder. With orphan designation in both Europe and the U.S., and a launch in Europe in the second half of this year, the acquisition will bring near term revenues as well as contribute to Shire's longer-term growth."

- see the release
- check out the AFX report
- and read the AP story

Alimera Sciences files $75M IPO

Alimera Sciences is braving a badly roiled public market with plans to push a $75 million IPO. The Atlanta-based biotech is developing ophthalmic drugs. Credit Suisse, Citi, Cowen and Co. and Leerink Swann are underwriting the IPO. Alimera has raised more than $71 million from a group of venture capital groups that include Scale Venture Partners, Domain Associates, Intersouth Partners and Polaris Venture Partners. In addition to developing new therapies, Alimera also markets OTC ophthalmic products. Report

Bayer dumps Titan drug on mid-stage failure

Titan Pharmaceuticals announced this morning that its Parkinson's drug Spheramine failed to hit primary and secondary endpoints in a Phase IIb trial for moderate to advanced Parkinson's disease. Researchers said there was no significant difference in response between the Spheramine group and the placebo arm. Titan says that it will analyze the data gathered on the 71 patients in the study.

Bayer, for its part, swiftly washed its hands of the program. "We will not develop (this drug) further and we will not invest in it further," said Bayer spokesman Jost Reinhard.

- see Titan's release
- read the report from RTT News
- and check out the story from AFX

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Poussot named chairman of Wyeth

Wyeth announced that Bernard Poussot, 56, its president and CEO, has assumed the additional position of chairman of the board.

Boehringer Ingelheim GmbH said its chief executive officer, Alessandro Banchi, will retire from his post at the end of the year and Andreas Barner, currently deputy CEO, will replace him.

Welichem Biotech has appointed Dr. Genhui Chen as president and CEO. York Yingping Guo resigned as president and CEO for personal and family reasons.

Akesis Pharmaceuticals has appointed Carl LeBel as its new president and COO.

IBT Laboratories announced that Maureen Loftus has joined the company as president and chief operating officer.

Tobira Therapeutics has named the following to its executive team: Sandra Palleja, MD, executive vice-president and chief medical officer, Angeline Shashlo, RPh, senior vice-president regulatory affairs and quality assurance, and Jay Rheingold, PhD, vice-president chemistry manufacturing and controls.

Rosetta Genomics has announced the resignation of Tamir Kazaz, the company's chief financial officer.

Covidien has appointed Michael Giuliani as vice president of research and development for pharmaceutical products and imaging solutions. The company also announced the appointment of James Young as vice president of research and development operations for pharmaceutical products and imaging solutions and Ralph Heasley as vice president of global R&D technology, pharmaceutical products.

Ikaria Holdings has named Deborah Petrowsky, M.D., F.C.C.P. as vice president for medical affairs and Steven Knapp, M.S., Pharm.D. was appointed vice president of regulatory affairs.

Prime Therapeutics announced the hiring of Jerry Steffl as vice president, government affairs.

Ambrilia Biopharma announced that Jinzi Wu, vice-president of preclinical and basic research, is leaving to join a U.S. pharma company.

Noven Pharmaceuticals named Anthony Venditti as its vice president--marketing & sales.

MDS Pharma Services has named Dr. Patrice Hugo to the position of vice-president of scientific affairs for its global central lab network.

Silence Therapeutics has appointed Annette Clancy and Jerry Randall as non-executive directors and Iain Rugheimer has resigned as a director of the company.

Chelsea Therapeutics International announced that William D. Schwieterman, M.D. has been appointed to the board of directors.

Celera completes its corporate transformation

Celera has ended its run as a biotech drug developer, completing its switch to molecular diagnostic testing company and moving its HQ from Rockville, MD to Alameda California. The Baltimore Business Journal tracked the arc of the company from high-flying genomics player to drug developer to molecular diagnostic testing company as it officially splits from Applera. Once counting a staff of 550, the Rockville operations have declined steadily over the years and have now reportedly been reduced to about 25. Acquisitions and expansions in California, meanwhile, swelled that staff to 550.

"It's a new day for Celera as we emerge as an independent healthcare company focused on personalizing disease management," said CEO Kathy Ordonez. "Our employees and our newly formed board of directors are energized about working together to build a successful future for our growing business, with its promising pipeline of new products and strong balance sheet."

- check out Celera's release
- read the report from the Baltimore Business Journal

Roche CEO: Emphasizing drugs for primary care

The new CEO at Roche is sending out some strong signals that the pharma giant's development process will include more new therapies for primary care. Roche is a big player in the field of hospital-based meds. But Severin Schwan (photo) is also emphasizing more experimental therapies that are bound for use by general practitioners to fight common diseases like diabetes.

"I do wonder whether the pharma model is really broken," Schwan tells the Financial Times in a wide-ranging interview. "I fundamentally believe if you are able to come up with innovative medicines including diagnostics, there will be demand."

Faced with a negative reaction to Avastin from regulators in the U.K., Schwan also noted that the best response was not to cut prices on therapies, but rather develop the kind of clinical data that would justify the use of a drug in a broader patient population.

- check out the story from the Financial Times

Maxygen inks $120M deal for hemophilia program

Maxygen has inked a deal to sell its hemophilia drug development program to Bayer for $90 million upfront and up to $30 million in milestone payments. The program is still in the preclinical stage, with the blood clotting protein MAXY-VII scheduled for Phase I human trials in a matter of weeks. Bayer also gained the nonexclusive use of Maxygen's MolecularBreeding technology for 30 specific gene targets.

"The agreement fits into our growth strategy for our specialty pharmaceutical business and builds on our expertise in the commercialization and manufacturing of protein therapeutics," said Gunnar Reimann, a member of Bayer's executive committee.

For Bayer, the development program offers a direct shot at building up its stock of therapies for hemophiliacs. Bayer already sells the blockbuster Kogenate, but the drug triggers an immune response in 20 percent to 30 percent of patients that makes the therapy ineffective. Bayer earned €233 million on Kogenate in the first quarter.

- here's the release
- check out the report from RTT News

MiddleBrook garners $100M investment; Pearl Therapeutics pockets $18M in venture funds;

> John Thievon was appointed CEO of MiddleBrook Pharmaceuticals as Equity Group Investments completed a $100 million investment in the company. The money will be used to market a new antibiotic and advance pipeline candidates. MiddleBrook release

> Pearl Therapeutics has closed an $18 million round of financing, bringing its total take in investment funds to $36.4 million. Pearl release

> Sciele Pharma has licensed the marketing and development rights to Addrenex Pharmaceuticals' ADX-415, an experimental therapy for hypertension and hot flashes. Addrenex stands to gain up to $27 million in milestone payments. Release

> Altea Therapeutics has forged a partnership with Hospira, for the development and commercialization of an undisclosed product using its PassPort Transdermal Delivery System. Altea report

> Steven Nissen (photo) of the Cleveland Clinic made a statement to the FDA that might hurt diabetes drug manufacturers--especially Bristol-Myers Squibb and AstraZeneca, which are currently in the FDA approval process with diabetes drugs. Nissen report

> After much back and forth and two days of deliberations in a seemingly endless Medicaid fraud lawsuit, an Alabama state court jury has ordered GlaxoSmithKline and Novartis to shell out some big bucks. Report

> One Equity Partners is on a shopping binge, it appears. The company, which recently purchased Prodigy Health Group for $110 million, has made an undisclosed offer to buyout the wound care portion of J&J's Ethicon division, which had $270 million in sales last year. J&J report

> AstraZeneca is celebrating today--or at least relaxing a bit. It has avoided a full-blown trial today to protect its top-selling antipsychotic medication, Seroquel. Report

> A professor at the University of Texas in Austin has created a virtual supercomputer to study metastasis. Report

> Looking to raise its profile with U.S. drug developers, Xceleron is set to open its new, $7.5 million lab in Germantown, MD later today. Xceleron report

> About 20 years ago, Harvard researcher Donald Ingber accidentally stumbled on a mold that demonstrated a remarkable ability to prevent the growth of small blood vessels. Cancer report

And Finally... The investment community has begun to line up for $6 million in biotechnology investment tax credits. The Maryland Department of Business and Economic Development says the program is designed to help persuade investors to back small, private biotech companies in the state. And economic development officials say the program has leveraged more than $24 million in biotech funds since 2006. The tax credit can be worth up to 50 percent of the investment. Article

Qiagen inks deal to buy Corbett

Qiagen is buying Corbett Life Science for $70 million down in cash and stock and another $65 million in milestones. Corbett manufactures and distributes life sciences instrumentation. Corbett is best known for the first rotary, real-time PCR cycler system--the Rotor-Gene. Report

SuperGen shares slide on late-stage Dacogen failure

Shares of SuperGen took a dive this morning after the company revealed that Dacogen failed a late-stage trial for the bone marrow disease MDS. Researchers say the drug failed to improve the median survival rate of patients when compared to a group receiving best standard of care. A total of 233 patients volunteered for the trial.

Dacogen is partnered with MGI Pharma, which is now owned by Japan's Eisai. Analysts say Dacogen's failure is a plus for Celgene's Vidaza, which is being relaunched this fall. Dacogen was approved in 2006.

- check out SuperGen's release
- read the AP report

CoLucid garners $25M in Series B money

CoLucid Pharmaceuticals says it has rounded up $25 million in Series B financing. New investor Care Capital led the round, which included previous investors Pappas Ventures, Domain Associates, Pearl Street Venture Funds and Triathlon Medical Ventures. The financing will be used to develop COL-144, a migraine compound, and to advance preclinical pipeline candidates that target neurological and psychiatric disorders.

"COL-144 is the first in a new class of migraine therapeutics and represents a paradigm shift in the treatment of migraine," said James White, Ph.D., President and CEO of CoLucid.

- check out CoLucid's release

ALSO: Ibis Biosciences, a unit of Isis Pharmaceuticals, has gained an additional $20 million investment from Abbott Laboratories. Ibis release