second half

Migenix cuts costs to stretch cash

Tue, 27 May 2008 06:59:55 -0400

Canada's Migenix is cutting its staff in an effort to preserve cash. The company, which is developing the anti-infective drug Omigard, cut six workers, reduced its CEO's salary and downsized its board of directors as it awaits results from a Phase III trial of the drug. Migenix says it's also looking into additional sources of funding as it develops Omigard and another drug, MX-2401.

"We must preserve our cash during this very difficult financial market for biotech companies. With the significant value-driving milestones we expect during the second half of this year and the first half of next year--along with the potential start of Omigard(TM) related revenues--we must take these actions to extend our cash runway as long as possible while continuing to advance our greatest product opportunities," said Migenix's CEO Jim DeMesa.

- check out the release
- read this report for more

Quark Pharma snares $27M for RNAi work

Mon, 07 Apr 2008 06:59:55 -0400

Quark Pharmaceuticals has garnered $27 million in a new round of venture financing. The RNAi developer attracted the support of SBI Asset Management and SBI Investment, subsidiaries of the prestigious SBI Holding Inc.

"The additional funding we are announcing today will allow us to significantly expand our clinical program," says Quark CEO Daniel Zurr. "Between our licensee, Pfizer, and Quark, we anticipate having Quark drug candidates in five clinical programs by the second half of 2008."

- read the release

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Mixed data for Renovo's scarring therapy

Mon, 03 Mar 2008 06:59:57 -0500

Renovo's Juvista produced a mixed set of data in two mid-stage trials. The drug produced positive data in reducing scarring but failed to demonstrate efficacy during a breast augmentation trial. Researchers also said that the therapy was more effective against scarring when administered twice and noted that during the breast augmentation trial the drug was administered once. Renovo plans to launch a Phase III trial of Juvista in the second half of this year. Shire, a partner on the drug, agreed to invest $75 million in Juvista, plus make a $50 million equity investment in Renovo.

"Shire is at present assessing these latest results with all other results produced to date and plans to discuss these with the FDA in 2008 to determine the regulatory path forward in the United States," said Renovo in a statement.

- read the press release for more information

Related Articles:
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Remoxy meets Phase III endpoint for pain

Thu, 06 Dec 2007 06:59:55 -0500

Pain Therapeutics and King Pharmaceuticals have announced positive results of a Phase III study of Remoxy for patients with chronic participated pain. Remoxy is an abuse-deterrent version of long-acting oxycodone. Remoxy has the benefits of oxycodone but can be prescribed by doctors who want to minimize the risks of abuse, misuse or diversion. With prescription pain drug use on the rise, preventing abuse is a major concern. Pain Therapeutics expects to file an NDA for Remoxy in the second half of 2008. If approved, Remoxy will be the first oxycodone on the market designed to deter abuse.

- see this release for more

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SPOTLIGHT: FDA demands delay Genzyme approval

Tue, 13 Nov 2007 06:59:53 -0500

Genzyme has been handed a letter from the FDA spelling out a new set of demands for data on Synvisc-One, a new version of its osteoarthritis drug that is dosed at twice a year. Genzyme says the agency's demands will delay an approval until the second half of next year. Report

Repeat after me: Stock prices will grow in autumn

Thu, 09 Aug 2007 06:59:55 -0400

There's a seasonal pattern to making gains on biotech stocks, says The Wall Street Journal, and '07 is playing out true to form. Just focusing on the Amex Biotechnology Index, you'll find an average 16 percent return on the field, with 80 percent of those gains being made in the second half of the year. With the vast majority of biotech companies running in the red, it's no big surprise that clinical data drives stock prices and the best data releases come at the big, second-half conferences attended by docs--or so the theory goes. But the market better pick up soon if '07 is going to follow previous years' pattern. Genentech and Amgen dominate the sector, and their stocks have trended downward. Oh, and don't forget one other market truth: If analysts were right all the time, or even most of the time, they'd be rich enough to retire very, very early.

- read the article from The Wall Street Journal (sub. req.)

Related Articles:
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Press Release: FDA Grants Chelsea Therapeutics Orphan Drug Designation for Droxidopa

Maureen Martino — Mon, 22 Jan 2007 13:02:07 -0500

FDA Grants Chelsea Therapeutics Orphan Drug Designation for Droxidopa
Multi-Center Pivotal Phase III Trial Planned for Second Half 2007

CHARLOTTE, N.C., Jan. 22, 2007 -- Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to its drug candidate Droxidopa for the treatment of symptomatic neurogenic orthostatic hypotension (NOH) in patients with Primary Autonomic Failure, a group of diseases that includes Parkinson's Disease, Pure Autonomic Failure (PAF) and Multiple Systems Atrophy (MSA).

The Orphan Drug Act provides for economic incentives to encourage the development of drugs for diseases affecting fewer than 200,000 people in the United States. Orphan Drug designation will entitle Chelsea to seven years of market exclusivity for Droxidopa in the treatment of symptomatic NOH. Additional benefits include tax credits related to clinical trial expenses, a possible exemption from the FDA-user fee, and assistance in clinical trial protocol design.

"Because of the U.S. Orphan Drug Act, there are incentives for companies like Chelsea to bring desperately needed drug therapies like Droxidopa to underserved patients who suffer from neurogenic orthostatic hypotension," said Dr. Horacio Kaufmann, the Alex and Shirley Aidekman Professor of Neurology, Mount Sinai School of Medicine and Director, Autonomic Disorders Research and Treatment Program. "Given its clearly delineated mechanism of action, extensive body of efficacy data and favorable safety reputation in the Japanese market, Droxidopa will help improve the health and quality of life for many patients with neurogenic orthostatic hypotension."

Chelsea plans to initiate a double-blind pivotal Phase III trial comparing Droxidopa to placebo at multiple sites in the U.S. and Europe during the second half of 2007. The trial is intended to assess the safety and efficacy of Droxidopa in patients suffering from symptomatic NOH associated with Parkinson's Disease, Pure Autonomic Failure and Multiple Systems Atrophy with the primary efficacy endpoint being defined as improvement in orthostatic blood pressure over time.

"Receiving this designation is an important step in both our clinical development and planned commercialization of Droxidopa, providing Chelsea with considerable strategic advantages by providing market exclusivity, reducing clinical development costs and facilitating future regulatory filings," said Dr. Simon Pedder, President and Chief Executive Officer of Chelsea. "With 7-years of exclusivity in place in the U.S. and 10-years in the EU, either under Orphan designation or as a new chemical entity, we have secured the necessary exclusivity to move aggressively ahead in our planned development of Droxidopa. We are pleased to have reached this critical milestone and look forward to working with the FDA to finalize our trial design and initiate our pivotal Phase III study later this year."

As part of its Orphan Drug strategy for Droxidopa, Chelsea also filed an application for Orphan designation for the treatment of symptomatic NOH in patients with Primary Autonomic Failure with the EMEA. Based on the timing of this filing, Chelsea expects to receive a determination regarding EU Orphan status late in the first quarter 2007.

About Droxidopa and Symptomatic Neurogenic Orthostatic Hypotension

Symptomatic NOH is a neurogenic disorder resulting from a deficient release of norepinephrine, the neurotransmitter used by sympathetic autonomic nerves to send signals to the blood vessels and the heart. This deficiency results in decreased blood pressure when a person assumes a standing position and is characterized by lightheadedness, dizziness, blurred vision and syncope. Droxidopa, an orally active synthetic precursor of norepinephrine, increases the supply of norepinephrine available for delivery to its receptors to improve orthostatic blood pressure and alleviate symptoms of orthostatic hypotension.

Chelsea estimates that nearly 300,000 patients suffer from chronic symptomatic neurogenic orthostatic hypotension (NOH) in the U.S. and EU combined. In the U.S. alone, there is a defined population of approximately 72,000 patients that experience chronic, symptomatic NOH associated with Primary Autonomic Failure, a group of diseases that includes Parkinson's Disease, Pure Autonomic Failure and Multiple Systems Atrophy.

In addition to creating significant health care costs, symptomatic NOH has a dramatic impact on the quality of life for those patients suffering from Primary Autonomic Failure. Midodrine, currently the only FDA approved treatment for orthostatic hypotension, not only fails to treat the underlying cause of symptomatic NOH but is limited in its use by a pronounced side-effect profile and black box warning for supine hypertension. Given the chronic nature of symptomatic NOH and the proven safety and tolerability of Droxidopa, Chelsea expects that daily oral treatment with Droxidopa should provide a significant improvement in the long-term treatment of symptomatic NOH.

Droxidopa, developed by and licensed from Dainippon Sumitomo Pharma Co., Ltd. (DSP), initially received Japanese approval in 1989 for the treatment of frozen gait and dizziness on standing associated with Parkinson's Disease and for the treatment of orthostatic hypotension, syncope or dizziness on standing associated with Shy-Drager syndrome and Familial Amyloidotic Polyneuropathy. In 2000, Droxidopa received expanded marketing approval to include prevention of vertigo, dizziness and weakness associated with orthostatic hypotension in hemodialysis patients. Droxidopa has historically generated annual revenues of approximately $50 million in Japan.

About Chelsea Therapeutics

Chelsea Therapeutics is a biopharmaceutical development company that acquires and develops innovative products for the treatment of a variety of human diseases. The Company is currently developing a library of metabolically inert antifolate compounds engineered to have potent anti-inflammatory and anti-tumor activity to treat a range of immunological disorders. Early clinical data suggests that Chelsea's lead antifolate compound, CH-1504, is a safe and effective treatment alternative to methotrexate for RA and may have further applications for psoriasis, IBD and certain cancers. Chelsea's antifolate program is complemented by a strategic partnership with Active Biotech AB for the joint development of a portfolio of therapeutics targeting immune-mediated inflammatory disorders and transplantation. In addition to its autoimmune pipeline, Chelsea is pursing an Orphan Drug strategy for the development of Droxidopa, an orally active synthetic precursor of norepinephrine, for the treatment of neurogenic orthostatic hypotension. Currently approved and marketed in Japan, Droxidopa has accumulated over 15 years of proven safety and efficacy, historically generating annual revenues of approximately $50 million in Japan.

This press release contains forward-looking statements regarding future events. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include reliance on collaborations and licenses, risks and costs of drug development, regulatory approvals, intellectual property risks, our reliance on our lead drug candidate CH-1504, our history of losses and need to raise more money, competition, market acceptance for our products if any are approved for marketing, reliance on key personnel including specifically Dr. Pedder, management of rapid growth, and the need to acquire or develop additional products.

Advanced Magnetics reports positive data in Phase III

Thu, 16 Nov 2006 19:01:35 -0500

Cambridge, MA-based Advanced Magnetics is touting positive results from its late-stage therapy for chronic kidney disease. The Phase III trial for the intravenous iron replacement therapy hit primary and secondary endpoints. Patients taking ferumoxytol who were not dependent on dialysis demonstrated a significant increase in hemoglobin. The trial results are being released today at the American Society of Nephrology's Renal Week in San Diego. Advanced Magnetics says that it's on track to submit an NDA in the second half of 2007.

- here's the release on the trial data

Alexion touts late-stage Soliris results

Sun, 11 Jun 2006 20:01:35 -0400

Alexion Pharmaceuticals says a second late-stage study of its anemia drug Soliris demonstrates the pharmaceutical is safe and well tolerated and hit all primary and secondary endpoints. Soliris is being developed as a therapy for PNH, a rare form of anemia that is triggered by a genetic blood disorder suffered by 8,000 to 10,000 patients in North America.

"We continue to target submission of marketing applications for Soliris in PNH during the second half of this year and we look forward to providing a further update this summer regarding our plans with U.S. and European regulatory agenciesm," says Alexion CEO Leonard Bell.

- here's the release from Alexion

GSK halts cancer trial on positive data

Sun, 02 Apr 2006 20:01:37 -0400

GlaxoSmithKline halted a late-stage clinical trial for its cancer therapy Tykerb after it exceeded its primary endpoint of time to disease progression. GSK will now move for regulatory approval for the drug in the second half of the year in Europe and the U.S. Researchers said that a combination therapy of Tykerb and capecitabine (Xeloda) versus capecitabine alone in women with advanced or metastatic breast cancer that have HER2 overexpression.

- read the AFX report

Arena prepares pivotal trial on obesity drug

Tue, 28 Mar 2006 19:01:37 -0500

Arena Pharmaceuticals says it will launch a pivotal trial of a closely watched obesity drug in the second half of the year after receiving positive safety data from a mid-stage trial. Preclinical toxicology studies indicate that APD356 did not harm heart valves or blood vessels in the lung. Phase IIb results are expected in June. Arena also said that it hoped to answer FDA questions about its insomnia drug APD125 from currently available data.

- read this AP report for more information

SGX shares soar on Novartis CML pact

Mon, 27 Mar 2006 19:01:39 -0500

Shares of SGX Pharmaceuticals jumped 40 percent this morning after the company announced it had signed a licensing deal worth up to $515 million with Novartis. In the deal, SGX will develop inhibitors for chronic myelogenous leukemia through Phase I. Novartis--which is paying $25 million upfront--will be responsible for late-stage development work. Researchers will look to provide a new therapy for people who develop a resistance to Novartis' Gleevec, which inhibits chromosomal abnormalities linked to leukemia.

SGX is retaining some co-commercialization rights of new oncology products in the U.S. SGX is planning on ramping up a North American commercial office with the planned launch of Troxatyl for third-line CML in the second half of next year. Troxatyl is currently in a Phase II/III trial.

- read the release for more information

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

Favrille wins fast-track designation for cancer drug Favld

Wed, 11 Jan 2006 19:01:37 -0500

Favrille has won the FDA's fast-track designation for Favld, a treatment for follicular B-cell non-Hodgkin's lymphoma following Rituxan. An ongoing Phase III trial of Favld should produce data on secondary endpoints late this year while primary endpoint data is expected in the second half of 2007. "This decision by the FDA has the potential to save us valuable time in the regulatory approval process, and also serves as an important acknowledgment of the potential for FavId in the treatment of B-cell follicular NHL," John P. Longenecker, Ph.D., CEO of Favrille.

- read this AP report for more information

Start-up opens with $98M in financing

Wed, 08 Jun 2005 20:01:39 -0400

A group of executives who helped guide Dura Pharmaceuticals to a $1.8 billion buyout by Elan five years ago have come back together to create a start-up that has gained $98 million in new financing. Verus Pharmaceuticals announced that it had secured a whopping $78 million in its first round and gained another $20 million in loans. The investors include Domain Associates and Prospect Venture Partners. Verus claimed it was a record sum for a start-up. The biotech plans to skirt the usual time spent in preclinical development, preferring to in-license later stage pediatric drugs with the goal of having a late-stage drug in development by the second half of 2006. Cam Garner, who ran Dura, is CEO of Verus.

- read this story from the San Diego Union-Tribune for more

Connetics plans new trial for Extina

Tue, 07 Jun 2005 20:01:38 -0400

Seven months after receiving a not approvable letter from the FDA for Extina -- an experimental skin treatment -- Connetics says it will begin a late-stage trial in the third quarter to prove it works. Extina was developed for an inflammatory skin disease called seborrhic dermatitis. Connetics says its new schedule will put it on track to file another NDA on the treatment in the second half of 2006.

- read this story from Forbes for more

Critical Therapeutics raising $54M

Mon, 06 Jun 2005 20:01:36 -0400

Critical Therapeutics of Lexington, Massachusetts, plans to raise $54.5 million in a private stock sale with a part of the funds going to relaunch its Zyflo asthma drug, acquired from Abbott last year. The launch is expected in the second half of this year. Other funds will go to advance its pipeline drugs.

- read this story from the AP for more