On 7/15/09, the Oncologic Drugs FDA Advisory Committee of cancer drug experts voted 14-1 against approval of Johnson & Johnson's (NYSE:JNJ) Yondelis (trabectedin) NDA, which seeks approval in combination with Doxil (doxorubicin) for the treatment of relapsed ovarian cancer in women. The expected PDUFA action date is 9/20/09 for a possible final FDA decision on this NDA. Final overall survival data for Yondelis is expected within about 18-24 months (early to mid 2011). The FDA Advisory Panel members were willing to reconsider the drug once final data is available and safety concerns were raised for the drug, including pulmonary embolism (blood clots in the lung), cardiac adverse events, and liver toxicity.
On 7/15/09, Cadence Pharma (NASDAQ:CADX) announced that its New Drug Application (NDA) for Acetavance (intravenous acetaminophen), its investigational product candidate for the treatment of acute pain and fever in adults and children, has been accepted for filing by the FDA and designated for a priority (six-month) review. The FDA has issued a PDUFA action date for the NDA of 11/13/09 for a possible decision by the Agency. The Company's 505(b)(2) NDA for Acetavance includes data from one pivotal clinical trial for the treatment of acute pain in patients following orthopedic surgery and one pivotal clinical trial for the treatment of endotoxin-induced fever.
The NDA is also supported by data from a total of nine placebo-controlled clinical trials, four active-controlled clinical trials, and seven other safety or pharmacokinetic clinical trials. The submission includes safety data from over 1,400 patients who received Acetavance in clinical trials, including 350 pediatric patients, from premature neonates to adolescents, and data from safety reports that collectively represent more than 53 million patient exposures to intravenous acetaminophen in countries outside of the U.S.
On 7/15/09, Watson Pharma (NYSE:WPI) announced the filing of an Abbreviated New Drug Application (ANDA) with the FDA seeking approval to market its trospium chloride extended-release 60 mg capsules prior to the patent expiration of the drug.Watson's trospium chloride extended-release capsules are the generic version of Allergan's (NYSE:AGN) Sanctura XR product (12-month U.S. sales of about $42 million thru 3/31/09), which is indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and urinary frequency.
AGN filed suit against Watson on 7/13/09 seeking to prevent generic competition prior to expiration of U.S. patent number 7,410,978, resulting in a stay of final FDA approval of Watson's ANDA for up to 30 months or until final resolution of the matter before the court, whichever occurs sooner. Watson believes it may be first to file an ANDA for generic trospium extended-release capsules.
On 7/15/09, Targacept (NASDAQ:TRGT) announced positive top-line results from a double blind, placebo controlled, flexible dose Phase 2b clinical trial of TC-5214 as an augmentation (add-on) treatment for major depressive disorder (MDD) in subjects who did not respond adequately to first-line treatment with citalopram (Celexa) alone. The result on the primary outcome measure for the trial, mean change between treatment (TC-5214 + citalopram) and placebo (placebo + citalopram) from baseline on the Hamilton Rating Scale for Depression-17, or HAM-D, was highly statistically significant in favor of TC-5214 on an intent to treat basis.
In addition, TC-5214 exhibited a favorable tolerability profile in the trial. The most frequent adverse events were headache, dizziness and constipation. TRGT plans to present detailed results from the Phase 2b trial of TC-5214 in October 2009 and expects Phase 3 clinical development to be initiated during 2Q10 following planned discussions with FDA and production of clinical trial material.
On 7/14/09, Watson Pharma (NYSE:WPI) announced that it received a Complete Response Letter (CRL) from the FDA on its New Drug Application (NDA) for TRELSTAR 22.5 mg (triptorelin pamoate for injectable suspension), a 24-week formulation of TRELSTAR for the palliative treatment of advanced prostate cancer. According to the CRL, the FDA has requested clarifications related to the clinical testing of the product, additional information regarding the chemistry, manufacturing and controls (CMC) of the product and other components, and information related to third party manufacturing.
Watson is working to ensure the requested information is provided to the FDA expeditiously. The new, longer-acting formulation of TRELSTAR is designed to be conveniently administered and to continuously suppress the production of testosterone in men with advanced prostate cancer for 24 weeks. TRELSTAR is an already proven therapy with established efficacy and safety in two formulations (a 4-week depot and a 12-week LA product).
On 7/14/09, Maxygen (NASDAQ:MAXY) announced the completion of a Phase 2a clinical study in breast cancer patients in which MAXY-G34 was safe and effective in reducing chemotherapy-induced neutropenia (CIN), a major side effect of myelosuppressive anti-cancer agents.
The Company stated that it is encouraged by the results and FDA feedback for the proposed development of MAXY-G34 and confirmed plans to seek a partnership for the timely and cost effective development to a BLA filing in 2013 for MAXY-G34, which has a product profile similar to Neulasta that would represent the second product in the multi-billion dollar, long-acting G-CSF market. n May 2009, Maxygen announced a licensing arrangement with Cangene (TSE:CNJ) for MAXY-G34 for acute radiation syndrome (ARS), while retaining rights to MAXY-G34 for all other indications. Maxygen continues partnering discussions regarding the out-license or sale of MAXY-G34 for chemotherapy-induced neutropenia.
On 6/15/09, BioDelivery Sciences (NASDAQ:BDSI) announced that the Company has reached agreement with the FDA on all aspects of its pending NDA for Onsolis (fentanyl buccal soluble film), including the REMS. Although the FDA did not meet its original PDUFA action date (big surprise, a delay by the FDA in meeting a decision deadline!) of 6/12/09, the FDA will not be issuing a review extension letter (which would have extended the decision deadline by three months) as their action on the NDA is forthcoming.
BDSI received a CRL from FDA on the NDA for ONSOLIS last August with the only deficiency being the new requirement for a REMS (which was NOT required at the time the NDA was originally submitted to FDA in October 2007). The REMS was formally submitted to the FDA on 12/12/08 and the submission was placed under a six-month (Class 2) review period. BDSI provided the following guidance and commentary, "Although we cannot pinpoint the exact timing of when the FDA's action might occur, we have previously indicated that we expect a 1H09 approval of the NDA for ONSOLIS. Based on our discussion with FDA last Friday, we should be within a few weeks of that target."
BDSI has adequate liquidity to fund normal operations and continue its clinical pipeline development through 4Q09 thanks to additional funding associated with the exercise of warrants. Earlier this year, BDSI raised $6 million in cash from partner Meda AB (STO:MEDAA) from a $3 million expanded marketing agreement and a $3 million advance of the milestone payment triggered by FDA approval and the U.S. launch of Onsolis.
The remaining $26.9 million cash milestone payment is due upon FDA approval and the expected 4Q09 U.S. commercial launch of Onsolis, which represents about 25% of the Company's current market cap. In addition to double-digit royalties that BDSI will receive on the sale of Onsolis, the Company is eligible for an additional $30 million in sales-related milestone payments and a $5 million milestone payment that is due upon European approval (expected 1Q10) and launch.
I am not concerned by the consistent selling by Elliott Associates/CDC over the past month as this hedge fund has a rocky relationship with the management team, which it tried to oust around three years ago. Also, shares of BDSI have increased by about 150% over the past year (even with the recent decline to the mid-$5 area) and the average trading volume is up even more - providing the chance for Elliott/CDC to take profits and liquidate most of their large position.
The rise in short interest to just over 1 million shares at the end of June for BDSI is also not concerning given the run-up in shares and trading volume as part of the Company's inclusion in the Russell 2000 Small-Cap Index on 6/26/09, the known delay in a final decision by the FDA to mid-July at the earliest, and the rise in average daily trading volume which equates to less than three days to cover the short interest.
During the 6/15/09 conference call, BDSI stated that Onsolis would already be on the market if not for the REMS requirement. Now that BDSI has reached agreement with the review team on the REMS; the Company is simply waiting for the FDA to issue its final decision on the NDA - which represents the first REMS submitted to the FDA for an opiate compound as part of the Agency's new requirements for this class of drugs.
Now that over a month has passed from the original PDUFA action date, the likelihood of final FDA approval becomes more likely after each passing day since the Agency did not issue a formal extension letter in June, which would have postponed a final decision by at least three months to 9/12/09.
ARNA plans to file a NDA with the FDA in December. However, patients who took lorcaserin 10 mg twice daily achieved an average weight loss of 5.9% of their body weight, compared to 2.8% for placebo, causing shares of ARNA to initially decline on the news (with a recent turnaround and uptick) based on concerns for the commercial prospects of lorcaserin compared to Qnexa from Vivus (NASDAQ: VVUS) ($11.51, +9%) (heavy, above-average volume), which is trading up on the lorcaserin results despite announcing a secondary offering of 9 million shares at a price of $10.50.
On 3/30/09, ARNA announced top-line results from its BLOOM clinical trial of experimental weight loss drug lorcaserin. The BLOOM results satisfy the efficacy benchmark in the most recent FDA draft guidance for the development of drugs for weight management. Lorcaserin treatment for up to two years was not associated with evidence of heart valve damage and rates for the development of echocardiographic FDA-defined valvulopathy were similar to placebo throughout the study.
On 9/18/09, Momenta Pharma (NASDAQ: MNTA) ($11.47, +3%) (above-average volume) was started with a buy rating by Deutsche Securities and the Company provided guidance at last week’s Rodman Healthcare conference that it is cautiously optimistic on the chances for approval of M-Enoxaparin by the end of 2009 and believes that the FDA has all the required data for a decision on the pending ANDA. In addition, MNTA will present full Phase 2a data on its proprietary anti-coagulant compound M118 at an upcoming conference on 9/24/09 while seeking a partnership to fund further clinical development and potential commercialization.
Click here for my overview article on MNTA at BioMedReports.com published in March which describes the Company’s three-part strategy that includes complex generics in partnership with Sandoz, proprietary compounds, and follow-on- biologics (FOB).
Momenta is partnered with the Sandoz division of Novartis (NYSE: NVS) to develop a generic equivalent (M-Enoxaparin) of the multi-billion dollar injectable blood thinner Lovenox ($3.9B in worldwide sales for 2008). While MNTA + NVS were not the first to file for a generic version of Lovenox, the 180-day exclusivity period awarded to the first-to-file company expired in April for Amphastar + partner Watson Pharma (NYSE: WPI).
The other company with a pending ANDA for Lovenox is Teva Pharma (NASDAQ: TEVA), which is also involved in litigation with Sandoz over the Copaxone ANDA. In late 2007, all three applicants with ANDAs for Lovenox received a request for more information from the FDA on the immunogenicity of their products. 9/26/08 is the date that Sandoz submitted its complete response to the FDA for the abbreviated new drug appplication (ANDA), and the Generic Drug Division does not issue formal decision date deadlines.
Sandoz filed its abbreviated new drug application (ANDA) for a generic version (M356) of Teva's multiple sclerosis drug Copaxone (glatiramer acetate injection) ($2.3B in sales for 2008) on 12/27/07 which was accepted for review by the FDA on 7/11/08. Sandoz is currently involved in litigation with TEVA over M356 as a generic equivalent which was filed with a Paragraph IV Certification. The P4 notification officially informed Teva that the M356 ANDA contains a certification of the patents listed for Copaxone in the FDA's Orange Book are either invalid or not infringed.
In April 2009, the FDA declined to review the citizen petition submitted by TEVA asking the agency not to accept applications for generic versions of the Copaxone multiple sclerosis treatment. The agency told Teva that it would be “premature and inappropriate” to review the Copaxone (glatiramer acetate) petition filed last September. A product cannot be launched until after the 30 month litigation stay (Feb. 2011) -- can then launch at risk if ANDA approved.
On 9/14/09, Mylan (NYSE: MYL) announced that the FDA accepted the Company’s ANDA for filing, seeking approval of Glatiramer Acetate Injection (20 mg/mL) as a generic version Copaxone. As previously announced, Mylan entered into a license and supply agreement with NATCO Pharma Ltd. which granted Mylan exclusive distribution rights for Glatiramer Acetate pre-filled syringes in the U.S. and other major global markets.
Disclosure: No positions. See my full disclaimer at MikeHavRx.com at the bottom of any page.
In late September, the Company raised net proceeds of approximately $46.7 million through a public offering of 4.6 million shares of common at $10.75 per share (compared to a current share price hovering around $9.50). Momenta provided guidance for ending the year with about $90-100 million in cash, providing adequate liquidity for 18-24 months. However, the most important development is a potential FDA decision for the long-standing abbreviated new drug application (ANDA) for M-Enoxaparin as a generic equivalent to the multi-billion dollar blood thinner Lovenox.
In late 2007, all three applicants with pending ANDAs for generic forms of Lovenox received a request for more information from the FDA regarding the potential for immunogenicity of their products. Momenta’s partner, the Sandoz division of Novartis (NYSE: NVS), submitted a major amendment on 9/26/08 for the M-Enoxaparin ANDA to address these concerns by the Agency. Most recently, the FDA conducted reviews of heparin suppliers in China to ensure a safe supply chain as part of the manufacturing process.
Sandoz has four heparin suppliers in China and a processing facility in Austria that have successfully completed inspections by the Agency. In addition, no patent litigation or other legal hurdles remain for Sandoz to launch M-Enoxaparin following FDA approval of the ANDA. Because the Generic Division of the FDA does not issue PDUFA action dates, the timing for an M-Enoxaparin decision is uncertain. However, Momenta feels that the Agency has all the necessary information required to make a final decision on the ANDA and believes a response from the FDA is possible before year-end.
The major uncertainty for financial projections this year is the status and timing of the M-Enoxaparin ANDA approval and launch. MNTA is set receive much higher royalties if M-Enoxaparin is the only generic form of Lovenox which is approved, as opposed to much lower royalties (e.g. 10%-15%) if competing ANDAs by Amphastar / Watson (NYSE: WPI) and Teva Pharma (NASDAQ: TEVA) are approved. Also, Sanofi-Aventis (NYSE: SNY) may choose to launch an authorized generic of Lovenox if one or more of the ANDAs are approved. The InvestorsHub page / forum for Momenta is an excellent resource for in-depth and current overviews on the Company, including several valuation scenarios for the stock.
Momenta / Sandoz also have a pending ANDA for a generic version (M356) of Teva’s multiple sclerosis drug Copaxone (glatiramer acetate injection) ($2.3B in sales for 2008), which was accepted for review by the FDA on 7/11/08. The Generic Drug Division of the FDA does not issue decision date deadlines and Sandoz is currently involved in litigation with TEVA over M356 as a generic equivalent that was filed with a Paragraph IV Certification / patent challenge.
In April 2009, the FDA declined to review the citizen petition submitted by TEVA asking the agency not to accept applications for generic versions of the Copaxone multiple sclerosis treatment. The Agency informed TEVA that it would be “premature and inappropriate” to review the Copaxone petition filed last September. A product cannot be launched until after the 30-month litigation stay (Feb. 2011), and then may be launched at risk if the ANDA is approved. On 9/14/09, Mylan (NYSE: MYL) announced that the FDA accepted the Company’s ANDA for a generic equivalent of Copaxone for the treatment of multiple sclerosis (MS).
In late September, Momenta reported the full results for its proprietary anti-coagulant (M118) in a Phase 2 EMINENCE trial that met its goal of supporting the feasibility and future clinical development of the compound in patients with coronary artery disease. M-118 represents the next-generation version of low molecular weight heparin (LMWH) blood thinners such as Lovenox. In June, MNTA announced top-line results from this study, which is a Phase 2a trial of its novel anticoagulant that enrolled approximately 500 patients undergoing percutaneous coronary intervention (PCI).
The primary analysis in the study provided evidence of non-inferiority of the combined M118 group (combining all three doses) as compared to the UFH (unfractionated heparin) group within the parameters of the prospectively defined analysis. The observed incidence of the composite endpoint was lower in all M118 treatment groups than in the UFH group; however it should be noted that the study was not designed or powered to detect statistically significant differences between treatments. The incidence of serious and non-serious adverse events was comparable in all treatment groups.
The final opportunity for Momenta lies in FOB products with several key elements to the strategy, including: global scale with partners such as Sandoz, establishing high-quality / low-cost manufacturing partners, the ability to differentiate FOB products from competitors, and achieving bio-equivalent or bio-better products rather than bio-similar products. Momenta will apply their technology platform to characterize highly complex biological agents and reverse engineer the production process to generate equivalent or improved complex biological compounds rather than products which are merely similar.
Momenta should have an inside track on its ANDA for Lovenox after previously working closely with the FDA on the tainted heparin crisis and their proprietary drug candidate M-118 serves as another potential catalyst in the form of a development / commercialization partnership opportunity. Legislation for FOB is not required for the two pending ANDAs (Lovenox, Copaxone) or the proprietary blood thinner M-118, but would increase the value of the Company’s technology platform by providing a defined path to commercialization for this class of products.
Disclosure: Long MNTA.
See my full disclaimer at MikeHavRx.com (bottom of any page).
Watson Pharmaceuticals, Inc. (WPI) reported third quarter earnings of 66 cents per share, a cent above the Zacks Consensus Estimate. Margin improvements resulting from operating efficiencies achieved through the company’s Global Supply Chain Initiative and contributions from new products helped increase earnings by 40% from the year-ago period. Revenues increased 3% to $662.1 million.
The Generic product division posted sales of $392.3 million, up 11%. The increase was driven by contributions from new products like the generic version of AstraZeneca’s (AZN) Toprol XL (potassium-chloride extended-release capsules) and Next Choice, which was partially offset by lower sales from omeprazole 40mg.
Approval of additional strengths of Toprol XL could drive sales further. The company raised the lower end of its previously issued 2009 revenue guidance for the generic segment by $5 million. Watson now expects generic segment sales in the range of $1.60 - $1.65 billion.
Brand product sales for the third quarter increased 1.9% to $96.1 million. Contributions from new products, Rapaflo and Gelnique, and increased sales of Androderm were partially offset by lower sales of Ferrlecit. Other revenues in the brand segment increased 41.9% to $16.6 million, thanks to increased revenue from the company's promotion of AndroGel and Femring. Watson revised its 2009 branded segment revenue guidance to $450 - $465 million (old guidance: $445 - $470 million).
Distribution segment net revenue declined 11% to $151.4 million, mainly due to fewer third-party generic new product launches which were partially offset by an increase in brand product sales. Distribution segment revenues are expected to come in at $620 million and $640 million (old guidance: $630 million and $660 million).
Watson continued to increase its investment in R&D and currently has 60 abbreviated new drug applications (ANDAs) filed with the U.S. Food and Drug Administration (FDA). The company reaffirmed its earnings guidance for 2009 and expects to deliver earnings in the range of $2.50 - $2.58.
Meanwhile, Watson remains on track to complete its acquisition of Arrow Group by year end. The Arrow acquisition will not only help the company expand its footprint in ex-U.S. territories, it will also boost Watson’s product offerings and pipeline significantly.
Companies featured in this segment: Westlake Chemical Corporation’s (NYSE:WLK), Teva Pharmaceutical Industries Limited (NASDAQ:TEVA), Novartis AG (NYSE:NVS), Watson Pharmaceuticals (NYSE:WPI), GDF Suez SA (EPA:GSZ), Iberdrola SA (MCE:IBE), Scottish and Southern Energy (LON:SSE), Siemens AG (NYSE:SI), Areva SA (EPA:CEI), Electricite de France SA (EPA:EDF), National Fuel Gas Company (NYSE:NFG), The Hinduja Group, International Power plc (OTC:IPRPY), NTPC Limited (BSE:532555), Ashok Leyland Limited (BSE:500477), Gulf Oil Corporation Limited (BSE:506480), Hinduja Foundries Limited (BSE:505982), IndusInd Bank Limited (BSE:INDUSINDBK), HTMT Global Solutions Limited (BSE:532859), RWE AG (OTC:RWEOY), E.ON AG (OTC:EONGY), Weyerhaeuser Company (NYSE:WY), VeraSun Energy Corporation (NYSE:VSE), and Valero Energy Corporation (NYSE:VLO).
All News |
Breaking News |
Featured Stories