Pearl Therapeutics grabs $65M in VC funding, moves COPD drug toward Phase III trials

Its main competition is seeking approval of a treatment for the lung disease COPD, but the leaders of Pearl Therapeutics Inc., and investors who just ponied up $65 million to push the company’s own COPD drug into Phase III trials, are unbowed.

Redwood City-based Pearl said Tuesday that current investors 5AM Ventures, Clarus Ventures and New Leaf Venture Partners participated in the Series D round led by Vatera Healthcare Partners.
Pearl will use the cash to start a Phase III program for its lead drug candidate, PT-003, for patients with chronic obstructive pulmonary disorder. That treatment is a combination of glycopyrrolate, which is a long-acting muscarinic antagonist, or LAMA, and formoterol fumarate, a long-acting beta-2 agonist, or LABA.

Theravance, GSK to start approval process for COPD drug by end of year

Theravance CEO Rick Winningham.

Theravance Inc. and partner GlaxoSmithKline wrapped up clinical trials around a drug that the companies could start submitting for regulatory approval later this year for chronic obstructive pulmonary disease. The once-a-day drug — called UMEC/VI for the molecules umeclidinium bromide and vilanterol — is one in a series of treatments that GlaxoSmithKline (NYSE: GSK) and South San Francisco-based Theravance (NASDAQ: THRX) hope to eventually sell to asthma or COPD patients. GSK and Theravance said Friday that they would start to submit UMEC/VI for regulatory approval "from the end of 2012."

Biotech Day: Tuesday's national biotech news

From the 40 business journals of American City Business Journals …

Biogen to fund mapping of ALS genome (Boston Business Journal)
Biogen Idec (NASDAQ: BIIB) has entered into a research collaboration with Duke University and the HudsonAlpha Institute for Biotechnology designed to sequence the genomes of up to 1,000 patients with amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease. The goal is to gain a better understanding of the genetic causes of ALS, in order to come up with better potential treatments.

Navigenics' Vance Vanier.

Life Technologies buys DNA test developer Navigenics (San Francisco Business Times)

Life Technologies Corp. bought genetic-information company Navigenics Inc., the company said Monday, giving the testing equipment giant an inroad to process lab tests for doctors. Carlsbad-based Life Technologies (NASDAQ: LIFE) did not disclose the value of the deal, but it said it is its "first step" toward building out its molecular diagnostics business through internal development, partnerships and select acquisitions. Foster City-based Navigenics, run by San Francisco Business Times 40 Under 40 award winner Vance Vanier, develops DNA tests that tell doctors if patients have genetic markers for certain diseases. It is one of a handful of companies that have taken advantage of faster, more accurate systems, like those offered by Life Technologies, to tap into consumers' interest in predicting and preventing diseases.


NuPathe resubmits migraine patch to FDA (Philadelphia Business Journal)

NuPathe is ready to take another shot at getting its migraine patch Zelrix approved. The company (NASDAQ:PATH) said it has resubmitted the treatment to the Food and Drug Administration. Last year the FDA raised chemistry, manufacturing and safety questions about the product.

Johnson & Johnson firm seeking new use for Simponi (Philadelphia Business Journal)
Janssen Biotech and Janssen Biologics are requesting Food and Drug Administration and European Medicines Agency approval to make their Simponi drug a treatment for "adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy."



A watershed moment in the fight against HIV (Boston Business Journal)

I caught my breath as I opened an email from the FDA Monday. The agency had for the first time approved a drug to prevent the spread of HIV, made by California biotech Gilead Sciences Inc (Nasdaq: GILD). This day is a day that has been the dream of patients, family members, activists, and medical providers throughout my entire adult life.

Related story: FDA approves Gilead's Truvada as first pill for HIV prevention (San Francisco Business Times)

Human Genome Sciences CEO Tom Watkins

Unknown future for Human Genome Sciences, execs after GlaxoSmithKline buyout (Washington Business Journal)

British pharmaceutical company GlaxoSmithKline PLC (NYSE: GSK) is snapping up Rockville-based Human Genome Sciences Inc. (Nasdaq: HGSI) for $3.6 billion, raising a host of questions over the local biotech’s future along the Interstate 270 corridor. It’s yet unclear how Glaxo plans to reshape its longtime partner, whether it will keep management in place or clean house — as in other recent big pharma acquisitions — and whether it will maintain Human Genome Sciences’ Maryland facilities.

MedImmune will open new center, shift 40 jobs to Hayward (San Francisco Business Times)

The South Bay's loss of MedImmune will be the East Bay's gain. The vaccine and infectious diseases drug developer said it plans to open a new translational sciences area for applied immunology and microbiology in Hayward as it closes facilities in Mountain View and Santa Clara.

Related story: MedImmune closures in Mountain View, Santa Clara will ax hundreds of jobs (San Francisco Business Times)

Moody's downgrades Thermo Fisher on Lamba acquisition (Boston Business Journal)

Moody’s Investors Service announced it would downgrade $6.6 billion of Thermo Fisher Scientific’s (NYSE: TMO) debt, just hours after the life sciences tools company said it would acquire California diagnostics firm One Lambda for $925 million in cash. Moody’s lowered the credit rating for Waltham, Mass.-based Thermo Fisher one notch to Baa1 from A3. The outlook is stable, Moody’s said.

Med-tech devices may get barcodes (Minneapolis-St. Paul Business Journal)

How do you place a unique identifying number on a medical device? That’s a question many med-tech companies will be considering in the coming years, thanks to proposed guidelines issued last week by the Food and Drug Administration. The FDA wants medical-device companies to use barcodes or other techniques to label each of their products. The program’s goal is to make it easier for the agency to determine whether particular devices are malfunctioning or otherwise harming patients. The FDA estimates the effort will cost the medical-device industry about $68.4 million a year.

Repros Therapeutics files protocol for mid-stage study of drug on clinical hold (Houston Business Journal)

Repros Therapeutics Inc. (Nasdaq: RPRX) said Monday it plans to submit to the Food and Drug Administratio  protocol for a phase 2 study of Proellex. Proellex is an oral drug intended to treat endometriosis and uterine fibroids. The FDA said it would change the drug’s full clinical hold to a partial clinical hold once the phase 2 protocol is approved.

GSK, Theravance seek FDA, European approval of COPD/asthma drug

Theravance CEO Rick Winningham.

Theravance Inc. and partner GlaxoSmithKline are asking regulators to approve a once-a-day treatment for patients with asthma and chronic obstructive pulmonary disease, a potential replacement for GSK's top-selling Advair.

South San Francisco-based Theravance (NASDAQ: THRX) and Glaxo (NYSE: GSK)said Friday that they asked the Food and Drug Administration to approve the drug, which would be branded as Breo, for patients with COPD, a kind of catch-all category for several smoking and environmental-related lung diseases like emphysema and chronic bronchitis.

The companies also are applying to the European Medicines Agency to use the drug, called Relvar in Europe, for treatment of COPD patients and asthma patients aged 12 years and older.

Five Prime strikes deal with GSK for asthma, COPD drugs

Five Prime Therapeutics Inc., a South San Francisco-based biotechnology company, has entered into a drug discovery collaboration with U.K.-based biotechnology giant GlaxoSmithKline — the second collaboration of its kind between the two companies.
The collaboration will give GlaxoSmithKline exclusive access to therapeutic drugs developed by Five Prime for refractory asthma and chronic obstructive pulmonary disease.

FDA targets October decision date for Impax Parkinson's drug

Impax Laboratories Inc.’s Parkinson’s disease treatment could be approved by late October, as the Food and Drug Administration accepted the Hayward company’s new drug application.
Impax (NASDAQ: IPXL), which last month said it will hire an undisclosed number of people as it prepares to sell the drug, said Thursday that its IPX-066 was given an FDA decision date of Oct. 21. The drug would be the first product from Impax's branded products unit, Impax Pharmaceuticals.

GSK 'finding' halts four trials of Anacor antibiotic

GlaxoSmithKline plc suspended enrollment in four trials of an Anacor Pharmaceuticals Inc. antibiotic after a “microbiological finding” in some patients in one of the studies.
The stock of Palo Alto-based Anacor (NASDAQ: ANAC) was down 36 cents, or nearly 5 percent, to $7.06 per share by mid-afternoon, after GSK said Monday that it suspended enrollment around GSK-052 in patients with complicated urinary tract infections.
The finding isn’t related to three other studies of the drug — a Phase IIb trial in complicated intra-abdominal infections and two Phase I trials — but GSK said it voluntarily suspended enrollment in those trials as well.

GSK to seek approval of Theravance lung drug

GlaxoSmithKline will seek approval of the COPD drug Relovair in the United States and Europe in mid-year, and it and partner Theravance Inc. will continue to talk to regulators about also using the drug for asthma patients.
The news initially appears to be a win for South San Francisco-based Theravance (NASDAQ: THRX), which co-developed the drug with GSK, after Astellas Pharma last week returned the antibiotic drug Vibativ to Theravance. But Theravance stock dropped Monday after GSK said it is investigating reports of fatal pneumonia in an undisclosed number of patients on the highest dose of Relovair.
That is not the dosage for which GSK (NYSE: GSK) will seek approval.

Impax asks FDA for approval of Parkinson's drug

Impax Laboratories Inc., traditionally a maker of generic drugs, submitted an application for its new treatment for Parkinson’s disease symptoms.
The Hayward company (NASDAQ: IPXL) said Wednesday that its branded products unit made the application for IPX-066 to the Food and Drug Administration.

Dynavax to get $3M in expanded deal with GSK

Dynavax Technologies Corp. added a new target to a research deal with giant GlaxoSmithKline PLC, and will get a $3 million milestone payment as a result.
Berkeley-based Dynavax (NASDAQ: DVAX) and GlaxoSmithKline (NYSE: GSK) added a new “toll-like receptor,” TLR8, to their agreement. They plan to study TLR8 and seek an inhibitor of it to treat autoimmune and inflammatory diseases.

GSK returns rights to 3 Anacor drug targets, expands deal on another

GlaxoSmithKline plc will return the rights to three drug targets to Anacor Pharmaceuticals Inc. but pay $5 million up front as it expands the deal around drugs zeroing in on a bacterial enzyme, malaria and tuberculosis.
Palo Alto-based Anacor (NASDAQ: ANAC) said the new deal could land another $11.3 million in milestone and research funding by the end of 2012.

Race is on for next-generation COPD drugs, but real payoff may be years away

Racing to get to market with new treatments for a common lung disease, drug developers may see an even more lucrative finish line further ahead.
First, however, drug developers are pushing new combinations of existing drugs or easier-to-use formulations.

Impax receives FDA warning letter for Hayward plant

Generic drug maker Impax Laboratories Inc. received a warning letter from the FDA regarding sampling and testing of drugs at its Hayward plant.
Impax (NASDAQ: IPXL), which also has its headquarters and research and development in Hayward, said it was cited by the Food and Drug Administration for sampling and testing of materials and drug products, production record review and the company’s process for inspecting the failure of some manufacturing batches to meet specifications.

Impax spending $52M to expand Taiwan plant

Pushed to the limit at its manufacturing plants and eyeing production of a Parkinson’s disease drug for GlaxoSmithKline, Impax Laboratories Inc. is undertaking a $52 million expansion of its year-old Taiwan facility.
Hayward-based Impax (NASDAQ: IPXL) said it would expand the 100,000-square-foot plant in Chunan, Taiwan, so it could produce up to 700 million tablets or capsules a year. An Impax spokesman did not say how large the expansion would be, but he said the plant currently can make as many as 450 million drugs a year.
The expansion, the first phase of a plan to increase the plant’s capacity to 1.5 billion tablets or capsules a year, should be completed by the end of 2012.

GSK to buy $129M in Theravance stock

GlaxoSmithKline PLC will buy about $129.4 million worth of stock in Theravance Inc. in a private placement, the companies said Monday.
London-based Glaxo (NYSE: GSK) agreed to buy 5.75 million shares for $22.50 each.
The purchase increases Glaxo's stake in South San Francisco-based Theravance (NASDAQ: THRX) to 19 percent.