Pharming

Pharming shares spike on positive Rhucin data

John Carroll — Fri, 11 Jul 2008 10:00:09 -0400

Shares of Pharming spiked 24 percent on the news that fresh data demonstrated that its lead therapy Rhucin--developed in genetically modified rabbits as a therapy for hereditary angioedema--proved safe and effective in patients involved in ongoing open-label studies. Investors responded to analysts' reports underscoring their belief that the new trial results would help Pharming achieve a regulatory win. One analyst estimated that a decision in Europe and the U.S. is unlikely to come before the second quarter of next year.

The data "confirm the clinical benefits of Rhucin, also in repeat treatment, without showing any adverse reactions or immune responses," said COO Bruno Giannetti. "Furthermore, the total number of treatments has substantially increased, including the successful treatment of serious potentially life-threatening laryngeal attacks."

- check out Pharming's release

Pharming shares sink after Rhucin gets thumbs down

Thu, 20 Mar 2008 07:59:57 -0400

There's new trouble for Pharming's Rhucin, an experimental treatment for hereditary angioedema. Pharming shares plunged after the company announced that the EMEA's Committee for Medicinal Products for Human Use is expected to refuse to approve Rhucin, saying that there is insufficient evidence of clinical benefits after repeated use and a possibility of immune system reactions. Pharming's shares were down about 27 percent after initially dropping by almost half.

Rhucin has been a major headache for Pharming since the EMEA first denied approval last December, sending its stock into a downward spiral. The drug is manufactured in the milk of transgenic animals and has long been held up as a leading example of the potential of transgenic therapies. But Pharming isn't giving up. "European denial for the drug is not the end for Rhucin nor for Pharming," Chief Commercial Officer Rein Strijker told reporters. The company insists that additional data will convincingly make their case for Rhucin and win eventual approval.

- see Pharming's release
- check out the ABN story

Related Articles:
Pharming says it's closing in on Rhucin approval. Report
Pharming steps up marketing plans on Phase III data. Report
Regulators focusing on transgenic animals. Report
Pharming gets orphan status for transgenic therapy. Report

ALSO NOTED: Acorda shares bounce on new data; Endo CEO hits the exit door; BioSante in protocol deal; and much more...

Tue, 29 Jan 2008 06:59:50 -0500

> Shares of Acorda Therapeutics took a big bounce yesterday when the company announced new data demonstrating that its multiple sclerosis drug Fampridine-SR does not raise heart-related risks higher than a placebo. Release

> Endo Pharmaceuticals CEO Peter Lankau has handed in his walking papers. Endo says he is leaving March 1 and will be replaced by its COO and CFO on an interim basis. Release

> BioSante Pharmaceuticals has reached agreement with the FDA on a special protocol assessment for its Phase III trials for LibiGel--a therapy for female sexual dysfunction. Report

> Following a recommendation from the FDA, NPS Pharmaceuticals is preparing a confirmatory late-stage study of Gattex in patients with short bowel syndrome. Report

> Shares of Medarex were buoyed yesterday by an analyst's remark that its cancer drug--ipilimumab--which delivered disappointing data in December, may yet demonstrate its ability to improve overall survival rates. Report

> Amsterdam-based Pharming says it expects a final EMEA decision on Rhucin in the second quarter and is close to detailing its request that the EMEA reexamine its application to market Rhucin in Europe. Report

> The FDA issued a warning letter to Replidyne regarding antibiotic faropenem medoxomil 300 mg. Letter

> Pipex Pharmaceuticals announced that its New Drug Application for oral tetrathiomolybdate has not been accepted by the FDA for further review as submitted. Release

> As if questions about the effectiveness of cholesterol meds weren't enough, now research is casting blood pressure remedies into doubt. Report

> Workers at Pfizer's Terre Haute, Indiana, plant where the ill-fated Exubera was made are, shall we say, less than exuberant today. The company has decided to cut 660 jobs there. Report

And Finally... Here's a troubling milestone: Bird flu deaths in Indonesia have hit 100. Report

ALSO NOTED: Shasun sets up NJ plant; Barrier gets a new CEO; Pharming gains grant; and much more...

Mon, 28 Jan 2008 06:59:50 -0500

> India's Shasun Chemicals has set up a processing unit for active pharmaceutical ingredients in New Jersey to supply U.S. customers. Report

> Chutes & Ladders: The chief operating officer of Barrier Therapeutics, Alfred Altomari, has been named CEO, succeeding Geert Cauwenbergh. Report

> Pharming has received a grant of €905,000 to research premature aging. Report

> German regulators have cleared Celgene's takeover of Pharmion. Release

> More than 100 allergic reactions, including one possible death, prompted Baxter International to recall its anti-clotting drug heparin. Report

> It's official: Merck's off-patent statin drug Mevacor can't go over-the-counter. Report

> The FDA has plans to review the controversial Enhance study. Report

> Is pharma addicted to producing blockbuster drugs? Report

And Finally… Opening up gorilla and chimpanzee reserves to tourists is raising fears that the animals will become infected by virulent human viruses. Release

ALSO NOTED: Savient shares soar on trial results; Pharming handed a rejection on Rhucin;ARCH closes $400M VC fund; and much mor

Thu, 13 Dec 2007 06:59:50 -0500

> It wasn't all bad news on Wall Street. Shares of Savient jumped almost 50 percent after researchers announced that its experimental gout therapy, Puricase, met the main goal of a late-stage trial. Report

> Pharming says that the CHMP in Europe has rejected its marketing application for Rhucin. The company says it will appeal. Release

> With Congressional committee breathing down its neck for the latest trial data on the cholesterol drug Vytorin, shares of Schering-Plough slid about 3.7 percent. Lawmakers want the data, but researchers in the project say they've delayed it due to the complexity of the information. Report

> Chutes & Ladders: Fundamental Applied Biology has raised $21 million in its second round and named former HGS VP Daniel Gold as its new chief executive. Report

> Just months after Pfizer stopped selling its inhaled insulin product, West Pharmaceuticals announced that it will slash 250 jobs in its Tech Group. Release

> Arch Venture Partners, a big player in the biotech arena, has closed its latest fund with $400 million to invest. Arch specializes in backing startups that rely heavily on new scientific research and entrepreneurial management. "We have a firm belief that investing in fundamental biotechnology innovations is one of the few areas that wins in cyclical economies." said Robert Nelsen, Managing Director. "We have seen our biotech platform companies do quite well throughout repetitive cycles, contrary to the industry trend toward 'product-only' companies. Our focus is on the most innovative opportunities, from pioneering technology to landmark products to expanding into unconventional markets." Release

> Lonza and BioWa will collaborate on creating an optimized production platform for more potent antibodies. Report

> The FDA has issued a new warning on carbamazepine, an epilepsy-slash-bipolar drug that can cause rare but severe side effects in certain patients of Asian descent. Report

> Surprise! You're the next CEO. So said Shire to CFO Angus Russell (photo), who got an unexpected promotion to the company's top slot. Report

> Scrub the gilt edge off those bonds. Fitch Ratings ripped the AAA rating off Pfizer's debt, citing the drug maker's "maturing" drug portfolio and its thinly populated pipeline. Report

And Finally… With 20 high-cost procedures leading the way, the nation's hospital bill jumped 7 percent in 2005, twice the rate of inflation. Report

Pharming raises $99M

Fri, 19 Oct 2007 06:59:55 -0400

Netherlands-based Pharming has raised $99 million (€70 million) through the issue of convertible bonds. The issue was managed by UBS Investment Bank. The company is also finalizing discussions for restructuring its financing agreement with Paul Capital Healthcare which Pharming entered into in February 2006. Pharming will repay Paul Capital EUR $13 million (€9 million) by the end of this year, with an additional $15 million (€11 million) to be paid in the first quarter of 2008.

Pharming is on the verge of a major European approval for Rhucin, a transgenic therapy made from rabbit's milk that's designed to treat hereditary angioedema. An announcement is expected sometime in this quarter.

- see this release

Related Articles:
Pharming says it's closing in on Rhucin approval. Report
Pharming inks creative drug partnering pact. Report
Pharming wins fast track review, shares jump. Report
Pharming gets orphan status for transgenic therapy. Report

Pharming shares jump on orphan drug designation

Thu, 11 Oct 2007 06:59:55 -0400

Shares of Pharming surged this morning after the Dutch biotech announced that it had won the FDA's orphan drug designation for recombinant human fibrinogen (rhFIB) for the treatment of bleeding in patients deficient in fibrinogen. Pharming is one of the leading developers of transgenic therapies, which uses animals as a low-cost production system.

"Pharming's development strategy for rhFIB will utilize the successful model of recombinant blood clotting proteins to control bleeding for various genetic and acquired deficiencies," says CEO Dr. Francis Pinto. "As Rhucin nears its first market authorization, rhFIB represents another avenue of growth for Pharming and demonstrates our strength in developing therapeutic recombinant proteins for unmet medical needs."

- check out the release

Read more on: Pharming | Transgenics

Pharming steps up marketing plans on Phase III data

Thu, 30 Aug 2007 06:59:58 -0400

Pharming says that its Phase III trial for Rhucin--a human protein developed to treat acute attacks of hereditary angieoedema--has hit its targets, opening the way to European and U.S. markets as the company pursues regulatory approvals on both sides of the Atlantic. With experts at the EMEA expected to give a thumb's up to Rhucin late this year, company officials reportedly believe that they are hot on the trial of a U.S. partnership deal that should include a substantial upfront payment. If all goes according to plan, Pharming tells the wire services, it will launch its therapy--derived from rabbit's milk--in Europe in the first half of '08. And FDA marketing application is expected later this year with an approval coming soon enough to launch in the U.S. soon after the therapy is introduced in Europe. Rhucin would be the second transgenic therapy to hit the market, and Pharming believes it has the potential to earn up to $820 million a year.

- check out the release on Pharming's Phase III

Related Articles:
Regulators focusing on transgenic animals. Report
Pharming says it's closing in on Rhucin approval. Report
Pharming inks creative drug partnering pact. Report
Pharming wins fast track review, shares jump. Report
Pharming gets orphan status for transgenic therapy. Report

Pharming says it's closing in on Rhucin approval

Mon, 20 Aug 2007 06:59:57 -0400

Pharming says that the positive interim results it has received from a study of Rhucin is blazing the way to EMEA approval. The Amsterdam-based developer says it expects EMEA approval in the fourth quarter and should be able to launch the drug, which treats hereditary angioedema, in early '08. The company says it is also just weeks away from completing a U.S. study, and should be able to submit data from that trial for FDA approval. Pharming expects the therapy should garner up to €600 million a year in both the U.S. and Europe. The drug developer's shares jumped about 25 percent on the news.

- see Pharming's release
- and here's the report from ABC Money

Related Articles:
Pharming inks creative drug partnering pact. Report
Pharming wins fast track review, shares jump. Report
Pharming gets orphan status for transgenic therapy. Report

Regulators focusing on transgenic animals

Mon, 30 Jul 2007 06:59:55 -0400

Genetically engineered animals are producing a range of therapies for human use, and The New York Times catches up on the action at companies like GTC Biotherapeutics in Massachusetts, Pharmathene and Pharming. Developing drugs in this field has been a slow and laborious task, and the FDA is now developing new guidelines to help govern how animals are used to produce therapies. Questions are also being asked about the ultimate fate of these animals. Should they be sold for food?

- read the article from The New York Times

Related Articles:
Transgenic chickens used to manufacture proteins. Report
GTC inks new transgenics collaboration deal. Report
EMEA rejects GTC's therapy from modified goats. Report
Pharming gets orphan status for transgenic therapy. Report