blood pressure

Pharmacopeia cuts 15% of workforce

Fri, 30 May 2008 06:59:57 -0400

In an effort to streamline its business and save cash, Pharmacopeia is laying off 15 percent of its workforce and decreasing "other expenses through improved operational efficiencies and increased financial discipline." The layoffs are part of the company's ongoing effort to focus resources on clinical and later-stage discovery programs.

Earlier this month Pharmacopeia announced positive trial results for PS433540, a hypertension drug. In a statement, interim CEO Joseph Mollica said it was the right time to put more resources towards the drug development. "In order to maximize shareholder value it is essential that we focus our efforts on the programs that can provide the greatest return," noted Mollica. The company is also testing PS433540 as a kidney disease treatment. Pharmacopeia expects the layoffs and other cost reduction efforts to save $10 million in 2009.

- see Pharmacopeia's release

Pharmacopeia shares rise on blood pressure data

Fri, 16 May 2008 06:59:54 -0400

Pharmacopeia's shares were up today on trial results for PS433540, a hypertension drug. Data showed 'significant' blood pressure reductions in a Phase IIa study in patients with mild to moderate hypertension. The company is also testing PS433540 as a kidney disease treatment.

"We are very pleased with the results of this important Phase IIa trial and look forward to future studies which will further assess the potential of PS433540, perhaps even beyond blood pressure lowering...We believe PS433540's dual mechanism of action may have a positive effect on diabetic kidney disease," said Joseph A. Mollica, Ph.D., Chairman of the Board and Interim President and Chief Executive Officer of Pharmacopeia.

- take a look at Pharmacopeia's release

ALSO NOTED: PDL offers bonuses to top execs; Radius earns $28.3M for milestone;Cytokinetics surges on positive data; and much m

Wed, 02 Apr 2008 07:59:50 -0400

> PDL BioPharma says it will pay four top executives nearly $1 million in bonuses through the end of next year to keep them on board as the company undergoes a transformation into an antibody development outfit. Story

> Radius Health has completed patient enrollment into its Phase II clinical trial of BA058 for osteoporosis. That milestone won the company a second-tranche financing of $28.3 million for a total second institutional investment of $67.5 million. Release

> Sirtris has won orphan drug status for its closely watched therapy resveratrol as a treatment for MELAS syndrome. Release

> Pfizer scooped up 87 percent of Encysive stock in a tender offer that closed on Monday. The $2.35 offer values Encysive at $195 million and a subsequent offering will now run through Friday for all remaining shares. Encysive has been developing new therapies for high blood pressure. Report

> Replidyne plans to pay its CFO and corporate development officer $250,000 bonuses to stay on with the company as it completes an unspecified deal. The biotech has been looking to partner up on its antibiotic drug faropenem medoxomil. Report

> Positive data for Cytokinetics' heart failure drug CK-452 helped spur the company's stock price. Mid-stage results demonstrate improved heart function in patients taking two doses of the drug. Final results from the Phase IIa are expected in the second half of the year. Report

> Shares of Kamada jumped 13 percent on the news that its late-stage trial in the U.S. for its Alpha-1 Antitrypsin treatment of congenital emphysema posted positive interim results. Release

> An experimental drug has demonstrated an ability to improve memory and slow the effects of aging in rats. Researchers believe the same drug--S18986--can interact with AMPA in human brains. Report

> Japanese scientists have found a way to deliver a payload of artificial molecules designed to prevent cells from secreting collagen, possibly pointing to a new approach to treating cirrhosis. Report

> The recent revelation in the New York Times that a tobacco company had quietly--some say secretly--funded a research program on lung cancer prompted the Boston Globe to go out in search of tobacco money behind local research groups. It didn't have to go very far. Report

> Intermune announced that an early-stage study of its experimental hepatitis C drug met safety endpoints and appears effective. The news sent its shares up 18 percent. Release

> A federal court struck down new patent rules that had several drugmakers up in arms, including GlaxoSmithKline. Report

And Finally... Should the feds fund studies to compare drugs' effectiveness? The idea appears to be gaining traction. Report

Cytos blood pressure jab could grab blockbuster market

Fri, 07 Mar 2008 06:59:58 -0500

Switzerland's Cytos stirred up some excitement with its announcement that new trial data backs up its hopes for a new vaccine that can be used to thwart high blood pressure. The therapy works by neutralizing a hormone--angiotensin--responsible for higher blood pressure. Researchers say the vaccine was linked with only mild side effects, such as flu-like symptoms. One of the key advantages of the vaccine, which theoretically could be on the market in about five years, is that the three annual injections required for therapy would go a long way to improving compliance. Researchers tested the jab on 72 people and Cytos plans to expand its investigations with much larger pools of volunteers.

A wide variety of therapies are on the market today, but patients frequently forget to take them. One of the reasons for the excitement in development circles is the likelihood that a successful new therapy would swiftly attain blockbuster status. A quarter of the population suffers from hypertension, making it a massive market.

"Immunization may be of particular benefit to people who find it difficult to stick to high blood pressure medication, but there is still a long way to go before this approach replaces the highly-effective current treatments," Professor Jeremy Pearson of the British Heart Foundation told the BBC.

- see the latest trial results on the vaccine
- read the article from the BBC
- check out the story from the Telegraph

Related Articles:
Can a vaccine control high blood pressure? Report
Cytos vaccine offers radically new approach. Report
Novartis, Cytos inks $500M anti-smoking vaccine pact. 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

Pfizer snags Encysive in $195M buyout

Wed, 20 Feb 2008 06:59:58 -0500

Pfizer has demonstrated once again just how interested it is in biotech with its $195 million deal to buy Encysive. The buyout expands Pfizer's pipeline for high blood pressure therapies, delivering the rights to Thelin. Pfizer says it will mount a late-phase trial to obtain FDA approval for Thelin, which has already been approved in a long lineup of European countries as well as Canada and Australia. Pfizer is making a $2.35 a share cash tender offer. Encysive's board has signed off on the deal, which is expected to close in the second quarter.

"The acquisition of Encysive will add growing, near-term revenue from the European market and increase our already strong presence in the cardio-respiratory arena with a product that complements Revatio, a PAH treatment that was discovered and developed by Pfizer researchers," said Ian Read, president of Pfizer's worldwide pharmaceutical operations. "We look forward to applying Pfizer's significant resources to the launch of Thelin in additional countries."

- see the release
- read the AP report

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Speculation soars over Pfizer's interest in biotech. Report
Struggling Encysive brings in Morgan Stanley. Report
Encysive CEO departs as pink slips fly. Report

NicOx pushes new naproxen version for arthritis pain

Mon, 19 Nov 2007 06:59:55 -0500

The Wall Street Journal reports on the progress that NicOx is making advancing a new version of naproxen for relieving arthritis pain. The French biotech is looking for a marketing partner for the drug, which adds nitric oxide to naproxen, relaxing blood vessel walls in a way that will allow patients to take the drug without the risk of higher blood pressure.

"We'll be the only one that will be able to show we're like placebo on blood pressure in long-term trials," said Michele Garufi, CEO of NicOxthe. NicOx may file for approval in early 2009.

- read the report from the Wall Street Journal's blog

Related Articles:
NicOx osteoarthritis drug fails comparison study. Report
NicOx escapes a requirement for major trial. Report
NicOx stock soars on $385M development pact. Report

Cytos vaccine offers radically new approach

Wed, 07 Nov 2007 06:59:58 -0500

Cytos Biotechnology has won a round of kudos for its experimental vaccine to control hypertension. CYT006-AngQb produced positive safety and efficacy data in a small Phase IIa trial of 72 volunteers with mild to moderate blood pressure. The therapy works by inhibiting angiontensin II, a molecule responsible for high blood pressure. One of the reasons why some top scientists are bullish about the therapy is that it offers an opportunity to treat the condition with an occasional jab, as opposed to a regimen of daily pills. And it's been delivering some impressive data in the clinic. Both doses of the drug worked to lower blood pressure in the trial, with the higher dose performing best. And the therapy appeared effective in lowering blood pressure during the early morning hours, when high blood pressure is particularly dangerous.

"The big hope is that you could give a few doses, and that would be it for life, then you wouldn't have some of the compliance issues related to taking medications on a daily basis," Daniel Jones, president of the American Heart Association, told the Washington Post. "Safety is the key thing. If this is proven safe, I really can't think of a downside."

- check out this release from Cytos
- here's the report from the Washington Post

Related Articles:
Novartis, Cytos inks $500M anti-smoking vaccine pact. Report
New tech drives huge growth in vaccine business. Report
New approach to vaccine development. Report
Vaccine "renaissance" attracts huge new venture investments. Report

King cuts 20% of workforce

Fri, 19 Oct 2007 06:59:56 -0400

Tennessee-based King Pharmaceuticals said it will cut its workforce by 20 percent due to problems the company is having with its Altace franchise. Last month King Pharmaceuticals lost its fight with Indian generics maker Lupin when a federal appeals court invalidated the patent on Altace, a drug for high blood pressure. The company is also speeding up plans to focus its business on neuroscience and hospital/acute. The cuts will save the company between $75 million and $90 million in 2008.

- see King's release

Related Articles:
King regroups after patent fight loss. Report
King bails on Palatin's FSM program. Report
FDA rejects King's Altace. Report

Wyeth's Pristiq shows benefits in clinical trial

Mon, 15 Oct 2007 06:59:55 -0400

Wyeth says that the nonhormonal desvenlafaxine, or Pristiq, demonstrated significant efficacy against hot flashes and night sweats in a clinical trial--but noted that high blood pressure and other troubling side effects were also seen in the data. Wyeth shares tumbled nine percent last July when the feds announced that they couldn't approve Pristiq without another trial on the heart and liver risks patients might be exposed to.

"There are more than 10 million menopausal women who experience moderate to severe hot flashes and night sweats. Only a small percentage of menopausal women use FDA-approved treatments, all of which are hormone-based," says Ginger Constantine, M.D., Vice President, Women's Health Care, Wyeth Pharmaceuticals. "Wyeth is committed to continuing to develop desvenlafaxine as a potential non-hormonal treatment option for women with moderate to severe vasomotor symptoms associated with menopause."

- here's the release for more info

Related Articles:
FDA approves Pristiq for depression. Report
Wyeth expects provisional OK for Pristiq. Report
FDA demands more data on Wyeth's Pristiq. Report

Read more on: Wyeth

Merck cautiously upbeat on cholesterol drug

Fri, 05 Oct 2007 06:59:57 -0400

Merck is looking to succeed where Pfizer so spectacularly failed. Merck presented positive Phase II data for its CTEP inhibitor anacetrapib, a drug designed to increase good cholesterol and decrease bad cholesterol. Anacetrapib significantly reduced LDL-cholesterol and Apolipoprotein B and increased HDL-cholesterol and Apolipoprotein A-1 both as monotherapy and in combination with Lipitor compared to placebo.

The key, of course, is creating a drug that doesn't increase blood pressure--the side effect that led to torcetrapib's demise. The question regulators will want answered is whether the mortality associated torcetrapib is common to the entire class of CTEP inhibitors. Roche is also developing a Phase II CETP-Inhibitor, R1658. Merck plans to evaluate what went wrong with torcetrapib before proceeding with the next stage of testing. Analysts estimate the market for such a drug could be $15 billion dollars.

- see this release on the data from Merck
- read the Star-Ledger article for more

Related Articles:
Merck's CETP program advances--with caution. Report
Merck scores high in race for cholesterol drug. Report
Pfizer halts Torcetrapib development. Report
Session to detail torcetrapib's stunning failure. Report

Palatin slashes staff following FDA objections

Wed, 26 Sep 2007 06:59:56 -0400

With its lead therapy raising some serious safety concerns at the FDA, Palatin Technologies announced that it is whacking about a third of its workforce. The move, which comes just two weeks after King Pharmaceuticals dropped out of its partnership with Palatin, will leave Cranbury, NJ-based Palatin with a workforce of 64 and is designed to save about $4 million in costs. Palatin has run into a roadblock with the development of bremelanotide. Regulators have questioned the drug's safety, noting a rise in blood pressure among volunteers taking the therapy. Palatin says it will continue on with a collaboration with AstraZeneca on obesity therapies as well as further developing a candidate for treating congestive heart failure.

- see the release on the cutbacks

Related Articles:
King bails on Palatin's FSM program. Report
Palatin researchers tout data. Report
Safety concerns force delay for Phase III ED trial. Report

Epix touts data on pulmonary hypertension drug

Tue, 07 Aug 2007 06:59:55 -0400

Shares of Epix Pharmaceuticals were buoyed this morning by positive data from a mid-stage study of a drug designed to reduce high blood pressure in the pulmonary artery. The trial of PRX-08066 involved 71 patients with pulmonary hypertension associated with COPD. Lexington, MA-based Epix also reported that its losses ballooned in the second quarter due to swelling R&D costs.

- see the release for more

Related Articles:
Epix shares soar on $1.2B pact with GSK. Report
Epix anxiety drug fails in late-stage trial. Report
Epix to buy Predix in $90M merger. Report

ALSO NOTED: Gentiae gains $16M in venture funds; Alexion kills pexelizumab program; Gentium gains Defibrotide rights;and much m

Tue, 02 Jan 2007 19:01:30 -0500

> Gentiae Clinical Research has gained $16 million in venture funds. The round was led by Bay City Capital. Report

> Alexion appears to have killed the development program for the anti-inflammatory pexelizumab due to discouraging Phase III data. Alexion had already released the data. Report

> Gentium has agreed to acquire the Italian marketing authorizations for Defibrotide and related trademarks, as well as certain other related assets, from Crinos S.p.A. for EUR 16 million in cash and other considerations. Release

> The FDA has approved the expanded use of Lilly's Byetta. Report

> Aerovance has announced positive top-line results from a Phase IIa trial of inhaled Aerovant in asthma patients. Release

> Tripos is selling its Discovery Research business in the U.K. to Provid Pharmaceuticals for $2 million. Report

And Finally... New research indicates that a moderate amount of alcohol can reduce the risk of heart attacks among men with high blood pressure. Article

ALSO NOTED: Shire drug gets second approvable letter; Galapagos acquires ProStrakan sub; FDA asks Allergan for more data; and m

Thu, 21 Dec 2006 19:01:30 -0500

> The FDA has issued its second approvable letter for Shire's ADHD drug Vyvanse. Report

> Galapagos has acquired ProSkelia, a French subsidiary of ProStrakan in a deal worth up to €45 million. Report

> Allergan has announced that the FDA has asked for more data on its eye pressure medication Combigan. Report

> The FDA has approved Novartis' Exforge for high blood pressure. Release

> Protiva Biotherapeutics has filed an appeal that seeks to overturn the BC Supreme Court's ruling that would permit Inex Pharmaceuticals Corporation to transfer the Inex-Protiva agreements to Tekmira Corporation without Protiva's consent. Release

And Finally... Drug reps will face a tough year in 2007. Report

SPOTLIGHT: Merck presents Arcoxia data

Tue, 22 Aug 2006 20:01:33 -0400

Merck's Arcoxia, billed as its replacement for Vioxx, demonstrated a comparable risk for cardiovascular events as the anti-inflammatory drug diclofenac, according to a preliminary analysis of its latest study data. But researchers noted that the number of volunteers dropping out of the study due to high blood pressure, edema and congestive heart failure were higher for Arcoxia. The FDA has issued an approvable letter for the drug, seeking more information on it before it makes a final decision. Report

EC approves Thelin as FDA continues discussion

Thu, 10 Aug 2006 20:01:38 -0400

The European Commission has approved Encysive's Thelin for pulmonary arterial hypertension, or high blood pressure in the pulmonary artery. The move came after the FDA decided it would need to see additional data on the drug before it could be approved. The FDA issued a second approvable letter for Thelin in late July, which Encysive officials say contained one outstanding issue. That raised analysts' concerns that Thelin would not be approved prior to the arrival of Myogen's ambrisentan. There has been some speculation that the FDA may be concerned with the way patients would respond to a combination of Thelin and warfarin, a standard therapy.

- see the release on Thelin for more information

Encysive shares surge on regulatory opinion

Thu, 01 Jun 2006 20:01:38 -0400

The EMEA also bolstered Encysive, sending its stock up 44 percent, with a recommendation in favor of the high blood pressure medicine Thelin. Thelin is Encysive's lead drug candidate. Just days ago, Encysive responded to the FDA's appovable letter from earlier this year, which had sent shudders through the ranks of analysts worried the agency might demand another trial of Thelin.

"The CHMP's positive opinion will now be considered by the European Commission, which is expected to issue a final decision regarding marketing approval for Thelin within approximately 90 days," Encysive noted. "Under the EMEA's centralized licensing procedure, if approved, Encysive would be granted marketing authorization for Thelin in all 25 member states of the European Union."

- read the article from TheStreet.com
- and here's more on the analysts and the FDA

Novartis files for FDA approval of Rasilez

Wed, 19 Apr 2006 20:01:37 -0400

The FDA has accepted the marketing application for an experimental therapy for blood pressure from the U.S. arm of Switzerland's Novartis. Novartis Pharmaceuticals is seeking approval of a renin inhibitor, Rasilez, that has demonstrated its effectiveness in lowering the blood pressure of patients. It has been tested in about 6,000 people suffering from high blood pressure, providing positive data for groups that include patients already on a blood pressure medication. Researchers have been working with an enzyme that is released in the kidney as a result of low blood pressure.

- here's the AP report on Rasilez

Novartis seeks OK for blood pressure combo

Thu, 02 Mar 2006 19:01:35 -0500

Novartis has filed for European approval of Exforge, a new therapy combining two treatments for high blood pressure. The drug developer says that Exforge--a combination of amlodipine and valsartan--has demonstrated excellent results in trials. About one in four adults suffers from high blood pressure.

"About two-thirds of patients currently take two or more drugs to control their blood pressure. This can be very problematic since the burden of having to take multiple pills is one of the main contributors to poor compliance. Exforge offers the powerful efficacy of two very potent drugs, achieving significant blood pressure reductions with good tolerability and the convenience of a single pill," said James Shannon, head of development, Novartis Pharma.

- here's the report from Pharmbiz