Takeda Receives FDA Complete Response Letter for the Investigational Fixed-Dose Combination...

DEERFIELD, Ill. and OSAKA, Japan, Takeda Pharmaceutical Company Limited ("Takeda") today announced that its wholly owned subsidiary, Takeda Global Research & Development Center, Inc. (U.S.), received on September 2 (U.S. TIME), a complete response letter from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for the fixed-dose combination (FDC) of alogliptin and ACTOS(R) (pioglitazone HCl). The FDA informed Takeda on June 26, 2009 that further review of the alogliptin monotherapy NDA would be conditional based upon additional data from a cardiovascular (CV) safety study that satisfies the statistical requirements of the December 2008 FDA Guidance titled, "Guidance for Industry: Diabetes Mellitus - Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes."

"This complete response letter from the FDA is consistent with the June 26 complete response letter for alogliptin, a key component of the alogliptin and ACTOS fixed-dose combination product," said Nancy Joseph-Ridge, M.D., general manager, Pharmaceutical Development Division. "The FDA recently agreed to the study design for a cardiovascular outcomes trial for alogliptin, titled EXAMINE, and patient enrollment is planned to begin this month. We anticipate

that the EXAMINE trial will provide the FDA with the information needed to continue the NDA reviews of both the alogliptin monotherapy and the alogliptin and ACTOS fixed-dose combination."

FDA Accepts Drug Application for Miconazole Lauriad(R) to Treat Oropharyngeal Candidiasis

Strativa Pharmaceuticals, the proprietary products division of a wholly owned subsidiary of Par Pharmaceutical Companies, Inc. (NYSE: PRX) , today announced that the U.S. Food and Drug Administration (FDA) has accepted the new drug application (NDA) for miconazole Lauriad((R)) mucoadhesive buccal tablets (MBT) to treat oropharyngeal candidiasis (OPC). Miconazole MBT delivers the antifungal miconazole via a mucoadhesive buccal tablet that is designed to enable once-daily dosing of the active ingredient at the site of infection.

The NDA submission was based primarily on data from a Phase III study demonstrating noninferiority to Mycelex((R)) Troche (clotrimazole)* in the complete resolution of signs and symptoms of OPC. The randomized, double-blind, double-dummy study was conducted in 577 HIV-positive patients in 40 sites in the United States, Canada, and South Africa.

"The NDA acceptance of miconazole MBT represents a significant milestone for Strativa Pharmaceuticals as this would be the first oral miconazole therapy available in the U.S. and would provide healthcare providers with a new option for treating OPC," said John A. MacPhee, president of Strativa Pharmaceuticals. "We believe miconazole MBT's delivery system and once-daily dosing schedule will offer an effective, convenient alternative to currently available local therapies, which require several doses per day to treat OPC." Strativa could launch miconazole MBT in the second half of 2010, if approved.

OPC, familiarly known as thrush, is an oral fungal infection most common in individuals with weakened immune systems -- particularly those with HIV/AIDS and those undergoing cancer treatments. OPC is a disruptive condition that results in lesions and inflammation in the mouth, and includes symptoms such as soreness, burning and/or altered taste.

Miconazole MBT was approved in 11 countries and is currently being marketed in several EU territories including France, Germany and the UK under the trade name Loramyc((R)). While miconazole MBT would be the first miconazole treatment available in oral form in the U.S., other dosage forms of miconazole have been marketed around the world. Under a licensing agreement with BioAlliance Pharma SA, Strativa is the exclusive U.S. distributor of BioAlliance's miconazole MBT. Upon FDA approval of the product, Strativa will pay BioAlliance $20 million, as well as a royalty on future net sales. BioAlliance may also be entitled to milestone payments if net sales achieve specified targets.

Acura Pharmaceuticals files briefing package for pain drug

Acura Pharmaceuticals, a specialty pharmaceutical company, has submitted a briefing package to the FDA addressing the issues raised in the FDA's June 30, 2009 complete response letter related to the new drug application for Acurox tablets.

Acura and King Pharmaceuticals R&D, are scheduled to meet with the FDA in late third quarter 2009 to discuss the complete response letter and the briefing package.

According to Acura, Acurox is an immediate release tablet with a proposed indication for the relief of moderate-to-severe pain. Acurox incorporates Acura's Aversion technology and is intended to discourage product misuse and abuse.

Acura and King, its exclusive licensee in the US, Canada and Mexico, are developing Acurox and three additional opioid analgesic products utilizing Aversion technology.

Affymax: independent committee positive on anemia drug

* Independent committee recommends drug trial to continue

* Still sees NDA filing in 2010

Affymax Inc (AFFY.O) said an independent data monitoring committee recommended the continuation of the company's late-stage trials of its experimental drug to treat anemia in chronic renal failure patients.

The biotechnology company, which is co-developing the drug Hematide with Japan's Takeda Pharmaceutical Co Ltd (4502.T), said the committee informed Affymax that safety data from two late-stage studies, called EMERALD and PEARL, support continuation of the studies.

Last August, Affymax and Takeda said they would stop developing the drug for the treatment of chemotherapy-induced anemia due to uncertain regulatory landscapes.

Hematide, a synthetic drug that would compete with biologic anemia medicines that have faced restrictions over safety and potential overuse concerns, is administered just once a month.

That could be a major advantage over current standard treatments from Amgen Inc (AMGN.O) and Johnson & Johnson (JNJ.N), which are given with dialysis about three times a week.

Affymax said it still expects to file for regulatory approval of the drug in 2010.

Shares of the company closed at $18.30 Friday on Nasdaq.

Novartis enters Japanese vaccines market

* Deal concerns vaccine for haemophilus influenza Type B

* Takeda Pharmaceuticals to be Novartis' partner

* Takeda to pay $1.06 mln upfront

ZURICH, - Swiss drugmaker Novartis (NOVN.VX) said on Tuesday it will enter the Japanese vaccines market through an agreement with local firm Takeda Pharmaceuticals.

The agreement concerns Vaxem-Hib, a vaccine for the Haemophilus influenza Type B (Hib).

Takeda will become the exclusive partner for Vaxem-Hib in Japan and will pay Novartis 100 million yen ($1.06 million) upfront as well as milestone and royalty payments.

Hib infection is responsible for an estimated 386,000 deaths per year worldwide, Novartis said in a statement citing WHO estimates.

Japan is the world's third largest vaccine market valued at $640 million and is expected to grow further.

Takeda will be responsible for conducting clinical trials and submitting a New Drug Application (NDA). Following approval, Takeda will label the product and sell the vaccine under the Novartis brand name. ($1=94.70 Yen)

Sagent Pharmaceuticals Announces Extension of Series A Financing

SCHAUMBURG, Ill., - Sagent Pharmaceuticals, Inc., a privately-held specialty pharmaceutical company, announced today that it has raised $30 million in a second Series A financing extension with pre-existing and new strategic investors. The round was again led by Vivo Ventures. This capital will be used to support upcoming product launches, development activities and strategic business objectives.

"Sagent's business model unites extensive pharmaceutical development, regulatory and manufacturing capabilities with the unique strength of our U.S. focused sales and marketing team to provide our hospital and clinical customers with a broad range of the highest quality injectable products," said Jeffrey M. Yordon, chief executive officer, founder and chairman of the board of Sagent Pharmaceuticals. "Since our inception in 2006, Sagent has successfully executed its strategy by filing more than 70 aNDAs to date, with more than 20 products expected in the market by year end. We appreciate our investors' continued confidence and commitment to Sagent."

Transcept Pharmaceuticals Inc reports Q1 net loss of USD8.5m

Transcept Pharmaceuticals Inc (Nasdaq: TSPT), a speciality pharmaceutical company, reported on 13 May a net loss attributable to common stockholders of USD8.5m (USD0.95 per share) for the quarter ended 31 March 2009. 

This is an increase from the net loss of USD5.1m (USD14.11 per share) for the quarter ended 31 March 2008.

The weighted average common shares used to calculate earnings per share were 9,003,067 and 359,602 respectively for the quarters ended 31 March 2009 and 2008.

During this year's first quarter Transcept recorded merger-related transaction costs of approximately USD2.2m.

Research & development expenses for the quarter decreased by USD1.4m to USD2.2m, with lower Intermezzo development costs following the submission of the NDA on 30 September 2008.

General & administrative expenses for the first quarter this year increased by USD2.7m to USD4.2m due to higher professional fees to operate as a public company, increased personnel costs primarily in marketing and administration, increased market research expenses and an increase in operational expenses associated with the addition of the Novacea office space in South San Francisco.

Cash, cash equivalents and marketable securities amounted to USD81.0m as of 31 March 2009.

LATITUDE Pharmaceuticals: Nanoemulsions Are a Superior Approach to Formulating Insoluble IV Drugs

SAN DIEGO--LATITUDE Pharmaceuticals, Inc. (LPI), a San Diego-based drug formulation developer, reported today that it is entering its fifth year of formulating a wide variety of poorly soluble/insoluble drug compounds using its proprietary intravenous (IV) nanoemulsion technology. To date, dozens of insoluble drug compounds have been formulated successfully with this approach and two (docetaxel and vinorelbine) are currently at the NDA-filing stage.

LPI’s unique nanoemulsions incorporate FDA-approved oils and lipids in a proprietary, non-liposomal and manufacturing-friendly process to produce low cost, stable, filter-sterilizable and lyophilizable drug-carrying formulations.

LPI’s easy-to-administer nanoemulsions are free of toxic solubilizers such as Cremophor®, polysorbate 80, DMSO, or other organic solvents that can cause adverse reactions. Their improved safety has been proven in human studies, which also showed the vein-irritation from phlebitis-inducing drugs could be eliminated.

LPI’s nanoemulsions have been successfully engineered to match the pharmacokinetic profiles of marketed drugs, enabling a rapid 505(b)(2) regulatory pathway. They can also lower the neurotoxicity of cytotoxic drugs and selectively deliver drugs to certain organs.

“Our nanoemulsion platform is a proven safer and more practical approach to formulating insoluble drugs. We are receiving substantial interest in this technology because of its success in formulating even the most insoluble new chemical entities and approved drugs,” noted Andrew X. Chen, Ph.D., President of LPI and the inventor of LPI’s nanoemulsion technology. “Drug developers can now capture the value of promising drugs that otherwise would be abandoned because of poor solubility or compromised with a less safe formulation.”

This advantageous technology is part of LPI’s formulation development repertoire and is covered by a suite of pending patents. Like LPI’s other technologies, the nanoemulsions are designed to add value to novel compounds and reformulated, off-patent drugs by providing additional intellectual property protection and other value-adding enhancements.

King Pharmaceuticals Reports First-Quarter 2009 Financial Results

BRISTOL, Tenn., - King Pharmaceuticals, Inc. (NYSE:KG) announced today that total revenues were $429 million during the first quarter ended March 31, 2009, compared to $432 million in the first quarter of 2008. The Company reported a net loss of $11 million and a diluted loss per share of $0.04 during the first quarter of 2009, compared to net earnings of $86 million and diluted earnings per share of $0.35 in the first quarter of the prior year. Excluding certain recurring non-GAAP adjustments and special items, adjusted net earnings equaled $64 million and adjusted diluted earnings per share equaled $0.26 during the first quarter ended March 31, 2009, compared to adjusted net earnings of $124 million and adjusted diluted earnings per share of $0.51 in the first quarter of 2008. 

Similar to its financial reporting in prior years, King reports financial results determined in accordance with Generally Accepted Accounting Principles ("GAAP") and adjusted financial results. However, beginning with the first quarter of 2009, King's adjusted financial results will exclude the amortization of intangible assets and non-cash imputed interest expense associated with the Company's $400 million 11/4% Convertible Senior Notes, as well as special items. For more information, see the "About Adjusted Financial Results" paragraph below.

Brian A. Markison, Chairman, President and Chief Executive Officer of King, stated, "During the first quarter, we moved closer to an approval of the New Drug Application (NDA) for EMBEDA(TM), our long-acting morphine formulation that is designed to deter common forms of misuse and abuse. Specifically, the Company received feedback from the U.S. Food and Drug Administration (FDA) regarding a Risk Evaluation and Mitigation Strategy (REMS) for EMBEDA(TM), and we are in discussions with the agency. We remain confident that EMBEDA(TM) will be approved in the near future."

Mr. Markison continued, "During the first quarter, King assumed full control from Pain Therapeutics, Inc. of all activities related to the development of REMOXY(R), a long-acting oxycodone formulation. As a result of the transition, we have set a new date with the FDA to discuss our planned responses to the previously received Complete Response Letter. We now expect this meeting to occur in the first half of July. We are also eagerly anticipating the approaching June 30, 2009 PDUFA date for the FDA's review of the NDA for ACUROX(R) Tablets, a short-acting oxycodone product that we are developing with Acura Pharmaceuticals. We remain excited about our extensive pipeline and the potential of our novel opioid medicines in development that are designed to reduce the risk of misuse and abuse commonly associated with existing medicines."

Joseph Squicciarino, King's Chief Financial Officer, stated, "During the first quarter, we substantially completed our integration initiatives associated with our December 2008 acquisition of Alpharma Inc. Additionally, we repaid a total of $48 million of principal on the long-term debt we incurred in connection with the acquisition, $33 million in excess of that required by our repayment schedule. During the remainder of 2009, we expect strong cash flow from operations which will continue to allow us to aggressively pay down our long-term debt, advance our pipeline and explore business development opportunities consistent with our strategy for growth."

As of March 31, 2009, the Company's cash and cash equivalents totaled approximately $437 million. During the first quarter of 2009, the Company generated cash flow from operations of approximately $17 million.

Net revenue from branded pharmaceuticals totaled $278 million for the first quarter of 2009, compared to $369 million during the first quarter of 2008. The decrease in revenues was primarily due to the market entry of generic substitutes for ALTACE(R) (ramipril) in December 2007.

Net sales of SKELAXIN(R) (metaxalone) totaled $101 million during the first quarter of 2009, compared to $116 million during the same period of the prior year.

THROMBIN-JMI(R) (thrombin, topical, bovine, USP) net sales totaled $47 million during the first quarter of 2009, compared to $67 million during the first quarter of 2008.

Net sales of AVINZA(R) (morphine sulfate extended release) totaled $39 million during the first quarter of 2009, compared to $32 million during the first quarter of 2008.

Net sales of FLECTOR(R) PATCH (diclofenac epolamine topical patch) 1.3% totaled $17 million during the first quarter of 2009. The Company added FLECTOR(R) PATCH as a result of its acquisition of Alpharma on December 29, 2008. As previously reported, the wholesale inventory level of FLECTOR(R) PATCH exceeded King's normal level as of the end of the fourth quarter of 2008. In the first quarter of 2009, King reduced these inventories to a level consistent with its other promoted products. Accordingly, first quarter 2009 FLECTOR(R) PATCH net sales were lower than prescription demand. The Company anticipates that net sales of this product should more closely reflect prescription demand beginning in the second quarter of 2009.

LEVOXYL(R) (levothyroxine sodium tablets, USP) net sales totaled $20 million during the first quarter ended March 31, 2009, compared to $16 million during the first quarter of 2008.

ALTACE(R) net sales totaled $10 million during the first quarter of 2009, compared to $80 million during the first quarter of 2008.

Revenues from the Animal Health business were $80 million for the first quarter ended March 31, 2009. The Company added the Animal Health business as a result of its acquisition of Alpharma.

King's Meridian Auto-Injector business contributed revenue totaling $57 million during the first quarter of 2009, compared to $43 million during the first quarter of 2008.

Royalty revenues, derived primarily from ADENOSCAN(R) (adenosine), totaled $15 million during the first quarter of 2009.

Jazz Pharmaceuticals, Inc. Announces First Quarter 2009 Financial Results

PALO ALTO, Calif., Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ) today announced financial results for the quarter ended March 31, 2009. Total revenues for the first quarter of 2009 were $22.1 million, compared to $14.6 million for the first quarter of 2008. Xyrem(R) (sodium oxybate) oral solution net sales for the first quarter of 2009 were $17.7 million, an increase of 56% over net sales of $11.3 million for the first quarter of 2008. This increase reflects the effect of significant price increases over the past twelve months and sales volume growth. Net sales of once-daily Luvox CR(R) (fluvoxamine maleate) Extended Release Capsules were $3.6 million for the first quarter of 2009.

Jazz Pharmaceuticals' cash and cash equivalents as of March 31, 2009 were $17.0 million. On March 31, 2009, Jazz Pharmaceuticals did not pay $5.1 million in interest due to the holders of the $119.5 million principal amount of its senior secured notes due June 2011, and Jazz Pharmaceuticals remains in default on the notes. The total overdue interest due on the notes through March 31, 2009 is $9.6 million.

"Our focus for the remainder of 2009 will be on increasing sales of our commercial products for their approved indications and submitting the NDA (New Drug Application) for JZP-6, our sodium oxybate product currently in Phase III clinical trials for the treatment of fibromyalgia," said Bruce Cozadd, Chairman and Chief Executive Officer. "We are pleased to report that we have completed the second pivotal trial for JZP-6 and expect to announce the results in mid-2009. We remain on track to submit our NDA for JZP-6 by the end of the year," he continued.

Research and development expenses for the first quarter of 2009 were $11.4 million, compared to $21.2 million for the first quarter of 2008. Reduced expenses in the first quarter of 2009 reflect Jazz Pharmaceuticals' decision that its JZP-4, JZP7, and JZP-8 programs will continue to the next phase of development only upon partnering or other funding for the programs.

Selling, general and administrative expenses for the first quarter of 2009 were $14.2 million, compared to $32.8 million for the first quarter of 2008. The decrease in the first quarter of 2009 reflects a decrease in spending on Luvox CR and the 2008 reductions in force.

Jazz Pharmaceuticals' net loss for the first quarter of 2009 was $13.0 million, compared to a net loss of $46.7 million for the first quarter of 2008.