Impax and Teva settle suit with over generic ADHD drug

Impax Pharmaceuticals Inc. and partner Teva Pharmaceuticals USA Inc. settled litigation over a generic ADHD drug copied from one that belongs to Johnson & Johnson Inc. Hayward-based Impax (NASDAQ: IPXL) has a deal with Israel's Teva (NYSE: TEVA) to make a generic copy of Concerta, or methylphenidate hydrochloride extended release tablets. Teva Pharmaceuticals USA is based outside Philadelphia and also makes generic drugs. The two companies did not give details of their settlement with the two Johnson & Johnson (NYSE: JNJ) units, Janssen Pharmaceuticals Inc. and Alza Corp.

Daniel O'Day to lead Roche Pharma as Pascal Soriot moves to AstraZeneca

Daniel O'Day.

Daniel O’Day, the former president and CEO of Roche Molecular Diagnostics in Pleasanton, will become chief operating officer of Roche Pharma as Pascal Soriot, who oversaw the tricky integration of Genentech Inc. into Roche, takes the helm of rival drug maker AstraZeneca. O’Day’s appointment is an important one, underscoring the Swiss drug maker’s commitment to developing companion diagnostics for its drugs. As COO of Roche Diagnostics since 2010, he has been a member of Roche’s executive committee. Roche CEO Severin Schwan noted in a press release late Monday night that O’Day has “a very impressive track record” in diagnostics and pharmaceuticals.

Biotech Day: Thursday's national biotech news

From the 40 business journals of American City Business Journals …

New SBA proposal could open R&D funds to foreign-owned firms (Washington bureau)
Proposed rules for the Small Business Innovation Research program could allow foreign-owned companies to compete for these federal R&D awards, according to the Small Business Technology Council.

Sanofi inks diabetes partnership with Brigham (Boston Business Journal)
French drug maker Sanofi (NYSE: SNY) has entered into a research agreement with Brigham and Women's Hospital to study the immunology of Type 1 diabetes, focusing on a target that has shown promise in animal studies.

Biotech center launches crops commercialization center (Triangle Business Journal)
The North Carolina Biotechnology Center has launched a new Biotechnology Crops Commercialization Center, which will be led by Monsanto veteran Alan Kriz.

Omeros will apply to FDA for trial of schizophrenia drug (Puget Sound Business Journal)
Seattle-based Omeros Corporation notified the Food and Drug Administration that the biotech company intends to submit an investigational new drug (IND) application this quarter for a medication expected to treat schizophrenia.

Medtronic may invest in India-based med-tech player (Minneapolis-St. Paul Business Journal)
Medtronic Inc. is negotiating an equity investment in Triviton Healthcare, a med-tech business based in India, reports theBusiness Standard.

Hemispherx seeks orphan status in Argentina for chronic fatigue drug (Philadelphia Business Journal)
Philadelphia-based Hemispherx Biopharma (NASDAQ:HEB) has filed a new drug application in Argentina for Ampligen, and is seeking orphan drug status for the product, which is intended to treat chronic fatigue syndrome.

Outgoing Impax CFO nets cash, health care benefits (San Francisco Business Times)
Departing Impax Laboratories Inc. CFO Arthur Koch Jr. will take a hefty benefits package with him.

Respironics announces voluntary recall (Pittsburgh Business Times)
Murrysville-based Respironics Inc. said it was voluntarily recalling about 85 ventilators suspected of possibly defective electronics.

Outgoing Impax CFO gets cash, health care benefits

Departing Impax Laboratories Inc. CFO Arthur Koch Jr. will take a hefty benefits package with him.

The Hayward-based generic drug maker (NASDAQ: IPXL) will pay Koch more than $1.15 million cash in equal installments over 12 months, according to a Securities and Exchange Commission filing Wednesday, as well as a lump sum cash payment of his pro rata target bonus for fiscal 2012 by March 15, 2013.

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.

FDA pulls Impax generic antibiotic as it approves Mylan dose

Impax Laboratories Inc. lost market exclusivity for its generic rendition of the antibiotic Doryx as competitor Mylan Inc. won approval for its version.
The Hayward-based drug maker (NASDAQ: IPXL) said Thursday that the Food and Drug Administration has “forfeited” Impax’s exclusivity for its 150-milligram generic Doryx.

Impax factory not yet cleared by FDA, may delay some drug approvals

Impax Laboratories Inc. said Thursday that the Food and Drug Administration hasn’t yet inspected a Hayward factory and that approvals of some drugs may be held up as a result.
Hayward-based Impax (NASDAQ: IPXL) got a warning letter from the FDA last year about the way drugs are sampled and tested at the factory.
Although it is still able to use the factory - the FDA didn’t shut it down - the downcheck can affect approval of drugs that list the factory as a manufacturing site.

Impax nabs AstraZeneca migraine drug, will hire 20 people

Impax Laboratories Inc. will add 20 people to its sales force, it said Wednesday, after licensing the AstraZeneca migraine drug Zomig for $130 million.
The move beefs up the branded products pipeline of Hayward-based Impax (NASDAQ: IPXL), known more for marketing low-cost generic drugs. But the deal with AstraZeneca (NYSE: AZN) could tie in to Impax’s generic business — it has focused on controlled-release generics and could apply the same technology with Zomig.

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.

Impax sued over potential generic cancer pain drug

On the cusp of major legislation for generic drug makers, Impax Laboratories said Monday that it is being sued over its generic version of Cephalon Inc.’s cancer pain drug Fentora.
Hayward-based Impax (NASDAQ: IPXL) said Teva Pharmaceuticals-owned Cephalon and CIMA Labs Inc. filed the patent infringement suit — standard operating procedure in the generic drug world — on Friday in U.S. District Court in Delaware.

New president of Impax generic drug unit to make $470K

The new president of Impax Laboratories Inc.’s generic drug business will be paid a base salary of $470,000, plus a one-time $75,000 hiring bonus, and work out of company offices in suburban Philadelphia.
Carole Ben-Maimon, who the Hayward-based company (NASDAQ: IPXL) said in September it had hired to run its global pharmaceuticals division, also can participate in Impax’s management bonus program and received an option to buy 75,000 shares of common stock and 24,000 shares of restricted stock, according to a Securities and Exchange Commission filing Wednesday.

GSK sues Impax over generic enlarged prostate drug

GlaxoSmithKline — the drug giant working with Impax Laboratories Inc. on a late-stage Parkinson’s disease drug — has filed a patent infringement suit against Impax around a generic version of its male health drug Jalyn.
It is at least the fourth such suit filed against Hayward-based Impax (NASDAQ: IPXL) in little more than five months because Impax regularly challenges the validity of patents while it seeks to be the first on the market with generic versions of those drugs.

Impax challenges patents of treatment for laughing, crying fits

Generic drug maker Impax Laboratories Inc. is challenging the patents of Avanir Pharmaceuticals Inc.’s Nuedexta as it tries to launch a lower-cost version of the drug.
Alameda-based Impax (NASDAQ: IPXL) said Wednesday that it has filed an abbreviated new drug application with the Food and Drug Administration for its version of Nuedexta, which treats pseudobulbar affect. PBA, as it is known, appears in some people with underlying neurologic conditions, causing involuntary, sudden and frequent episodes of laughing or crying.

Impax touts success of Parkinson's drug in late-stage trial

Impax Laboratories Inc. said a treatment for Parkinson’s Disease that it is testing with GlaxoSmithKline did well in a Phase III clinical trial.
Hayward-based Impax (NASDAQ: IPXL) has been working since December with GlaxoSmithKline (NYSE: GSK) on the drug, IPX-066.
Impax, which typically focuses on generic drugs, is developing IPX-066 through its “branded products unit,” Impax Pharmaceuticals.

Impax profit falls in Q2

Generic drug maker Impax Laboratories Inc. reported lower sales and profits in the second quarter than a year ago.
The Hayward company (NASDAQ: IPXL) earned $12.5 million in the June quarter, down from $31.3 million a year earlier. Sales fell to $125.9 million, down from $153.1 million a year earlier.

Impax expects Parkinson's trial data by end of August

A late-stage trial of an Impax Laboratories Inc. drug, designed to control involuntary muscle jerks experienced by Parkinson’s disease patients, will report early results in late August.
Assuming positive results from the Phase III trial of Impax’s IPX-066, Hayward-based Impax (NASDAQ: IPXL) said it would file a new drug application with the Food and Drug Administration in the fourth quarter.

Impax to pay $790K severance to former operations chief

Impax Laboraties Inc. will make a $790,434.50 severance payout to departed operations chief Charles Hildenbrand, according to a Securities and Exchange Commission filing by the company.

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.

Taiwan lands $30M commitment from Burrill, promise from Impax

When Christina Liu, minister of Taiwan’s Council for Economic Planning & Development, came through the Bay Area on a whirlwind U.S. tour last month, it was anything but a getting-to-know-you session.
San Francisco life sciences merchant bank Burrill & Co. agreed to invest $30 million, according to Taipei Times. Likewise, Hayward-based Impax Laboratories Inc., which has a production facility in Chunan Science Park, promised further investments, the newspaper said.