Forest Lboratories

Phenomix dumps IPO, inks Forest Labs deal

Calisha Myers — Thu, 23 Oct 2008 10:56:20 -0400

San Diego-based biopharma Phenomix has cancelled its $86.25 million initial public offering. The Novartis-backed firm filed for an IPO back in January, but cited "market conditions" as its reason for withdrawing the IPO.

The company, which was founded in 2001, is currently developing treatments for type 2 diabetes and hepatitis C. It's lead candidate is an oral DPP-4 inhibitor for type 2 diabetes, dutogliptin (PHX1149), which is currently in phase III clinical trials. In addition to NovartisBioVenture fund, leading its long list of investors are JP Morgan, Nomura Phase4 Ventures, Delphi Ventures, Alta Partners, Sofinnova, Baker Brothers, CMEA Ventures and GBS Venture Partners.

There was some good news from the company today, however. Phenomix and Forest Laboratories have inked a $340 million deal to develop and commercialize Phenomix's type 2 diabetes candidate, dutogliptin (PHX1149). Under the terms of the agreement, Forest will make an upfront $75 million payment to Phenomix. The two companies will equally share the profits and expenses of the development, commercialization and marketing in the U.S. Phenomix could receive up to $340 million in upfront and milestone payments for development in U.S. markets. Phenomix was a 2007 Fierce 15 company.

- see the release on the deal
- check out the IPO story in Mass High Tech

ALSO NOTED: FDA OKs Novalar therapy; StemCells files new patent suit; and much more...

Mon, 12 May 2008 06:59:50 -0400

> The FDA has OK'd Novalar's OraVerse (phentolamine mesylate) for the reversal of soft-tissue anesthesia and the associated functional deficits resulting from a local dental anesthetic. Novalar release

> StemCells has filed its second patent suit against Neuralstem claiming two human neural stem cells patents were violated. Report

> Takeda and Affymax have posted more positive mid-stage data for their experimental anemia therapy. Release

> Pipex Pharmaceuticals is reporting that the FDA has provided orphan drug status for oral tetrathiomolybdate as a therapy for Idiopathic Pulmonary Fibrosis. Pipex release

> Forest Laboratories and Daiichi Sankyo have ended a co-promotion deal for Azor, a combo therapy of two antihypertensives. Forest release

> Big-name cholesterol meds are losing ground on two fronts. Report

> Politics are clouding the process of tracing contaminated heparin back to its source or sources--politics that go way beyond the typical Democrats-versus-Republicans grandstanding. Report

> With Big Pharma cutting back, CMOs are picking up the slack. The worldwide market for biopharmaceutical contract manufacturing reached $2.4 billion in 2007, a year-over-year leap of 14 percent. CMO report

> Back in 2005, Swedish pharma monitors raised a red flag on GSK's HIV fighter abacavir and its possible link to heart attacks, The Independent is reporting. Report

> According to India-based Dr. Reddy's CEO, the U.S.'s financing industry is "a complete mess." Report

And Finally... Depressed teens that self-medicate with marijuana only trigger more serious mental ailments. Release

ALSO NOTED: Endo buys Novartis' Voltaren; Microbia, Forest produce positive Phase III data; and much more...

Wed, 05 Mar 2008 06:59:50 -0500

> Endo Pharmaceutical is buying Novartis' Voltaren gel for $85 million upfront and a one-time sales milestone of $25 million. Release

> Researchers for Microbia and Forest Laboratories have produced positive Phase II data from two studies of linaclotide in patients with chronic constipation as well as patients with irritable bowel syndrome with constipation. Release

> MorphoSys has inked a deal to supply genetically engineered antibodies to Spain's Proteomika SL for use in research into diagnostics and novel treatments. Release

> After some arm-twisting from the FDA, Roche has added stronger warnings to its Tamiflu label. Report

> A new study shows that costlier drugs may work better. Report

> Another prominent South Korean biomedical researcher stands accused of faking data that appeared in prestigious scientific journals. Report

> Leaders in the nanotech field have been beating a path to Congress, asking lawmakers to significantly boost federal support of research into molecular-level advances. Report

> Hormones produced by the heart could play a remarkable role in controlling and perhaps even curing cancer. Report

> Forget those studies of long-lived Italian shepherds and Greek fishermen. It's not fresh air or exercise or a simple whole-foods diet that causes certain people to live past 100, a new study shows. Instead, it's a set of genetic mutations thought to interfere with normal cell growth and thus slow aging. Report

And Finally... Several of the world's top biomedical research institutes--including a couple run by biopharma giants--have made this year's list of the best places for postdocs to work. Report

ALSO NOTED: Sirtris, NCI collaborate on cancer models; Kylin expands in Indiana; and much more...

Thu, 21 Feb 2008 06:59:50 -0500

> Sirtris announced a collaboration with the National Cancer Institute to its enzyme activators in cancer models. Report

> Kylin Therapeutics in Indiana has been expanding with the help of funds provided by the state's Economic Development Corp. Report

> The Los Angeles Times reports on the growing profitability of the HIV drug sector, which has been particularly beneficial to Gilead Sciences. Article

> Sirion Therapeutics has licensed rights to develop eye therapies using a anti-inflammatory agent developed by Bridge Pharma. Release

> LA-based ImmunoCellular Therapeutics announced today that Manish Singh, Ph.D., MBA has taken on the full-time position of president and CEO. Release

> Eurand has been granted a priority review by the FDA for Zentase--EUR-1008. Release

> Forest Laboratories and Cypress Biosciences say the FDA has agreed to review their NDA application for milnacipran, a treatment for fibromyalgia. Report

> Medical device makers got some supreme protection yesterday. The highest court raised a partial shield against lawsuits, saying that devices that passed the FDA's most stringent premarketing review are exempt from consumer lawsuits. Report

> A Nobel Prize-winning biologist says that researchers are no closer to developing a vaccine against HIV than they were 20 years ago, when the scientific quest began. Report

> Can a vaccine control high blood pressure? Report

> There's growing evidence around the U.S. that the flu jab offers only marginal protection against the seasonal ailment. Report

> In 2007, drugmakers jacked prescription prices up 7.8 percent. Report

And Finally…The CDC says the U.S. has made enormous efforts to prepare for a health crisis, like a flu pandemic, but cautions that an enormous amount of work remains to be done. Article

ALSO NOTED: GTC announces positive ATryn data; NC biotech center to expand; FDA delays Requip XL decision; and much more...

Tue, 05 Feb 2008 06:59:50 -0500

> Shares of GTC Biotherapeutics were buoyed after the company announced positive results from a late-stage study of ATryn among patients with hereditary antithrombin deficiency undergoing high-risk surgical or childbirth procedures. Release

> The North Carolina Biotechnology Center is planning to add 25,000 square feet in order to expand its conference activity and add new workers. Report

> Forest Laboratories reported positive preliminary results from a Phase III trial of its once-daily formulation of memantine HCI for Alzheimer's. Report

> The FDA is delaying a decision on Requip XL, a reformulated Parkinson's drug from Glaxo and Skyepharma. Report

> Proteome Sciences says it has no idea what's behind recent movement in its share price. Report

> Chutes & Ladders: Altus Pharmaceuticals announced today that Sheldon Berkle has resigned as president, CEO and a member of the board of directors. Release

> Some time back, Wyeth's Pearl River, NY, facility spawned seven discrimination lawsuits. Current and former employees alleged that the company discriminated against them because they're black. Now one of those cases is in court. Report

> Researchers have overcome one of the chief obstacles to developing a vaginal gel to protect poor women from HIV infection. Report

> Researchers targeting new treatments for the common cold can now look forward to getting help from a new mouse model for the ailment. Report

> A prostate cancer vaccine developed at the University of Southern California was able to prevent the disease in 90 percent of mice engineered to develop cancer. Report

> Do generics cost more in long run? Report

And Finally... Researchers have combined the DNA of three people in one embryo, pointing the way to producing children who will be free of inherited disease. Report

DEALS: Teva buys CoGenesys for $400M

Thu, 31 Jan 2008 06:59:52 -0500

Teva buys CoGenesys for $400M

DEALS
WHO	WITH	WHAT	SCOOP
Pfizer	Washington University	$25M	Washington University and Pfizer researchers will identify, design and execute projects focused on immuno-inflammatory disorders such as arthritis, asthma and diabetes.
Forest Laboratories	Novexel's	$109.6 million	Forest gains development rights to Novexel's intravenous beta lactamase inhibitor, NXL 104, in combination with Forest's ceftaroline.
Teva	CoGenesys	$400 million	Teva says the buyout will give it a better position to compete in the fledgling biogeneric field.

Forest inks $219M deal for combo drug program

Wed, 23 Jan 2008 06:59:55 -0500

Forest Laboratories has put up $109.6 million to snare development rights to Novexel's intravenous beta lactamase inhibitor, NXL 104, in combination with Forest's ceftaroline. And Forest could pay out up to $109.6 million more for a successful combination program. Forest gains exclusive rights to administer the combination drug in North America. The ceftaroline/NXL 104 combination goes into Phase I trials in fiscal 2009. Forest also gains first negotiation rights to a second use of the combination for a different clinical activity.

"The significant funding which Novexel will receive under this agreement will enable the company to devote the appropriate resources to the parallel and independent Phase II development of NXL 104 in combination with ceftazidime," said Novexel CEO Iain Buchanan. Novexel was a 2007 Fierce 15 company.

- and check out the release
- read the report from Pharmaceutical Business Review

Related Articles:
Lexapro, Namenda boost Forest. Report
Drug combos not a sure thing. Report

ALSO NOTED: Paion inks $102M deal; Sepracor chairman plans retirement years;and much more...

Wed, 02 Jan 2008 06:59:50 -0500

> Sepracor Chairman Timothy Barberich is planning to retire. He will receive $1.65 million a year under a retirement pact. Report

> After being abandoned by Forest Laboratories, Germany's Paion has inked a $102 million development deal for the stroke drug desmoteplase. Release

> Forest Labs and Cypress Biosciences have submitted an NDA for milnacipran for fibromyalgia syndrome. Release

> The UK's Axa Framlington Health says the threat of an economic slowdown has not hampered its investment strategy in biotech. Report

> The CEO of Charles River Laboratories has exercised his options for 30,000 shares of common stock. Report

And Finally… We weren't the only ones to take a look back at 2007. Here's the Guardian's take on the year past. Article

New "me-too" beta blocker dissed by experts

Wed, 19 Dec 2007 06:59:54 -0500

The Wall Street Journal health blog pokes fun at Bystolic, the newly approved beta blocker from Forest Laboratories and Mylan Laboratories, as the ultimate "me-too" drug. It's number 19 in the list of beta blockers now available in the U.S. The developers counter by saying that the drug has "placebo-like" side effects, making compliance easier. One Mayo Clinic expert cautions the numbers are coming from small studies, and with Glaxo's Coreg going generic, he's going with the lower cost drug.

- read the blog item

Related Articles:
Mylan CEO intent on new global biz. Report
Mylan takes majority stake in Matrix. Report

ALSO NOTED: Burrill bullish on M&As; Nebivolol wins approval; Arrowhead Research names CEO; and much more...

Mon, 03 Dec 2007 06:59:50 -0500

> G. Steven Burrill is touting the (relative) success of his Burrill Biotech Select Index compared to the swooning Nasdaq and sounds quite bullish about the impact of M&As in biotech. Report

> The FDA has approved an NDA from Forest Laboratories and Mylan for nebivolol, or Bystolic, for hypertension. Forest is planning to launch in January, saying that the FDA's concerns about a backup facility can be dealt with quickly. Release

> Apparently, GlaxoSmithKline's dynamic duo is worth $4.1 million each. The two execs passed over for the CEO job--Chris Viehbacher (photo) and David Stout (photo)--will each get a retention package worth that much if shareholders approve. Report

> Prepping for his January inauguration, CEO-in-waiting Bernard Poussot (photo) has tapped a handful of current Wyeth-ites to fill top positions in the company. Report

> Henry Waxman, chairman of the House Committee on Oversight and Government Reform, is protesting an off-label marketing "loophole." Report

> Chutes & Ladders: Arrowhead Research has named Christopher Anzalone as CEO and is in the process of buying the private equity group he founded. Report

> AEterna Zentaris has closed on the $3.2 million sale of Echelon Biosciences to Frontier Scientific. Release

And Finally… Intelligent software may be the key to developing the perfect artificial hand. Release

ALSO NOTED: Novartis plots $700M biotech plant; Genzyme wins marketing approval; Glenmark, Forest to pursue Phase II; and much

Mon, 29 Oct 2007 07:59:50 -0400

> Novartis will plow $700 million into a new cell-culturing facility in Singapore. The plant will boost the drug maker's capacity for biotech drugs, delivering products for commercial distribution and for clinical development. Report

> Genzyme has won FDA marketing approval for Epicel, a therapy for severe burns. Release

> Researchers at Glenmark Pharmaceuticals and Forest Laboratories have been given a partial favorable response for an additional mid-stage study of GRC 3886 for asthma and COPD. Report

> Warburg Pincus has wrapped its $3.67 billion buyout of Bausch & Lomb. Release

> Shares of Dusa Pharmaceuticals surged this morning on the news that it had settled a patent dispute with River's Edge Pharmaceuticals regarding Nicomide. Report

> Look for a crackdown on direct-to-consumer ads if John Edwards is elected in 2008. Report

> You win some, you lose some. Bayer is abandoning plans to launch a bigger dose of its multiple sclerosis treatment Betaferon. Report

> Outgoing GlaxoSmithKline CEO Jean-Paul Garnier is shouldering the heavy load of layoffs and restructuring to give his successor Andrew Witty a clean slate when he takes over next May, the Times of London is reporting. Report

And Finally... Scientists from Bangor University have found a 400-year-old clam, the oldest living animal known to science. Report

Schizophrenia drug gets mixed results in IIb

Tue, 16 Oct 2007 06:59:56 -0400

Forest Laboratories and Hungary's Gedeon Richter says that high doses of its antipsychotic drug failed to demonstrate a statistically significant response in a Phase IIb trial, but low doses of RGH-188 reflected "nominally" significant results. Research will continue to determine if the therapy can work as a treatment for schizophrenia. A full set of data will be released in a few weeks, when analysts can get a better idea of what "nominally statistically significant" means.

- see the release for more information

Related Articles:
New schizophrenia drugs no better than generic. Report
Lilly's schizophrenia drug may offer breakthrough. Report
Forest Labs dumps failed stroke drug program. Report
Mice engineer to be schizophrenic. Report

Read more on: Forest Labs | Schizophrenia

Microbia, Forest ink $330M deal

Mon, 17 Sep 2007 06:59:58 -0400

Microbia is pocketing a $70 million up front payment from Forest Laboratories in exchange for a 50/50 U.S. development pact for linaclotide, an experimental therapy for irritable bowel syndrome and other gastrointestinal problems. Forest gains exclusive rights to the drug in Canada and Mexico and will help pay development costs. If all goes according to plan, Microbia will garner up to $330 million in the deal. The therapy is currently in Phase IIb. Microbia was a 2006 Fierce 15 company.

- see the release on the deal

Related Articles:
Microbia lands whopping $75M fifth round. Report
Forest Labs dumps failed stroke drug program. Report
Forest buys Cerexa in $480M deal. Report

Forest Labs dumps failed stroke drug program

Thu, 30 Aug 2007 06:59:55 -0400

Faced with the Phase III failure of Desmoteplase for stroke in June, Forest Laboratories has bailed on its development partnership with Paion. Paion's other unlucky licensee, a troubled Lundbeck, said two months ago that the late-stage study revealed no statistically significant difference between the way Desmoteplase patients responded when compared to a group taking a placebo. Paion, for its part, says it is evaluating other options while Lundbeck has yet to announce its decision pending a full analysis of the data. Forest's departure does carry some benefits, though, as it pays out €4.3 million to cover research and development costs.

- read the release for more

Related Articles:
Forest buys Cerexa in $480M deal. Report
Forest halts enrollment as researchers study safety signal. Report
Forest to pay Mylan $75M for nebivolol rights. Report

DEALS: GSK licenses Genmab's HuMax-DC20 for $2.1B

Wed, 03 Jan 2007 19:01:32 -0500

GSK licenses Genmab's HuMax-DC20 for $2.1B

DEALS
WHO	WITH	WHAT	SCOOP
GlaxoSmithKline	Genmab	$2.1B licensing deal	The deals is for Genmab's HuMax-CD20 antibody for leukemia.
Amgen	Cytokinetics	$675M development deal	The deal covers CK-1827452, which triggers a protein that causes the heart to contract as it pumps blood.
Forest Laboratories	Cerexa	$480M buyout	Forest gains development and marketing rights for three antibiotics, including one--ceftaroline acetate--which is poised to begin a late-stage trial for skin infections.
Vectura Group	Unnamed company	$63M development pact	Vectura has been working on a copycat version of Glaxo's best selling asthma drug Advair, which loses patent protection in 2010.
Bristol-Myers Squibb	Exelixis	$60M development deal	Exelixis is responsible for selecting small molecule drugs for specific targets while BMS has the right to choose up to three candidates for three targets.
GlaxoSmithKline	Praecis Pharmaceuticals	$54.8 buyout	Praecis will provide chemical-synthesis and screening technology that will GSK will use with it's own discovery capabilities.
Genentech	Exelixis	$40M development pact	Genentech and Exelixis have agreed to a global development pact for XL-518, an MEK-inhibitor for tumors.
Genentech	Altus	$30M development deal	The pact covers ALTU-238, an experimental human growth hormone being developed as a once-weekly therapy.
Centocor	FivePrime Therapeutics	$15M collaboration pact	FivePrime Therapeutics will work with Centocor Research on the development of new therapies for osteoarthritis and pulmonary fibrosis.
PerkinElmer	Euroscreen Products	Buyout	Euroscreen markets products to laboratories engaged in drug discovery work. This is ElmerPerkin's seventh acquisition of the year.
Otsuka Pharmaceutical	Bristol-Myers Squibb	Licensing deal	Otsuka Pharmaceutical has licensed the Japanese rights to Bristol-Myers Squibb's saxagliptin, being studied for the treatment of Type 2 diabetes.
Schering-Plough	Valeant Pharmaceuticals and Metabasis Technologies	Licensing deal	Schering-Plough has licensed the experimental pradefovir for chronic hepatitis B. Valeant licensed the drug from Metabasis six years ago.

Forest buys Cerexa in $480M deal

Wed, 13 Dec 2006 19:01:38 -0500

Forest Laboratories has joined the lineup of drug developers bidding their way to new prospects with its agreement to buy the antibiotic developer Cerexa for $480 million in cash. Forest gains development and marketing rights for three antibiotics, including one--ceftaroline acetate--which is poised to begin a late-stage trial for skin infections. It could be launched in 2010 or 2011. If its sales break the $500 million mark in any 12-month period after the five years it is launched, Cerexa's investors will get an additional $100 million payday.

"Ceftaroline is an important late-stage development product that can address serious and life-threatening infections in the hospital setting including MRSA," said Howard Solomon, chairman and CEO of Forest. Cerexa was a 2006 Fierce 15 company.

- see this release on the deal
- here's the AP report on the buyout

Related Articles:
Forest halts enrollment as researchers study safety signal. Report
Forest to pay Mylan $75M for nebivolol rights. Report
Cerexa raises $50M, plans Phase II trials. Report

Enrollment halted as researchers study safety signal

Tue, 24 Oct 2006 20:01:34 -0400

Potential safety issues have prompted Forest Laboratories and its development partner, Germany's Paion, to halt enrolling patients in a late-stage trial of a compound that mimics a protein found in bat saliva. The independent monitoring committee says they want time to analyze more of the data from the drug, desmoteplase, to evaluate a "safety signal." No other details were provided. Desmoteplase is a clot-dissolving protein intended as a treatment for stroke.

- see the release on the trial

ALSO NOTED: Forest files suit against Caraco; Cephalon R&D chief sees potential; and much more...

Tue, 11 Jul 2006 20:00:50 -0400

> Forest Laboratories is suing Caraco Pharmaceutical Laboratories claiming patent infringements on the antidepressant Lexapro. Report

> Cephalon's R&D chief says Wall Street is underestimating the market potential of its experimental cancer therapies. Report

> Germany's GPC Biotech has filed another part of its marketing application for the cancer therapy satraplatin. Report

> Kos Pharmaceuticals has filed a drug application with the FDA for a new form of its Niaspan cholesterol therapy. Report

> Array BioPharma has pocketed $18 million of the $32 million it will receive from a sale-leaseback deal. Report

And Finally… A new study says that people taking a potion made from a hallucinogenic mushroom reported mystical experiences that led to behavioral changes that lasted for weeks. Researchers urged people not to try to replicate this study at home. Article

SPOTLIGHT: FDA OKs generic Lexapro

Mon, 22 May 2006 20:01:33 -0400

A subsidiary of Israel's Teva has received FDA approval to begin marketing a generic version of the blockbuster depression drug Lexapro. Forest Laboratories' Lexapro earned $2 billion last year. Report

Forest to pay Mylan $75M for nebivolol rights

Wed, 11 Jan 2006 19:01:38 -0500

Forest Laboratories has agreed to pay Mylan $75 million for the development rights to the hypertension drug nebivolol in the U.S. and Canada. Forest also agreed to a series of unspecified milestones for the successful development of the drug, and took responsibility for sales and marketing. Final approval of the beta blocker requires meeting FDA conditions outlined in an "approvable letter" sent to Mylan last May. Mylan has completed a pre-clinical study of the drug in order to respond to the FDA. Mylan says it will submit new data to the FDA in the second half of this year.

- read this AP report