Key Developments: Forest Laboratories Inc (FRX)
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18 Jun 2013
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Latest Key Developments (Source: Significant Developments)
Forest Laboratories Inc's CEO Solomon To Step Down At Year End-Reuters
Reuters reported that Howard Solomon, Forest Laboratories Inc's Chief Executive Officer for more than 35 years, will retire at the end of this year, capping a tenure that saw the Company morph from a small generic and vitamins maker to a $10 billion corporation. Solomon will continue in the chairman role until the annual shareholder meeting in 2014. Full Article
Almirall SA and Forest Laboratories Inc Announces Positive Phase III Combo Results from its Second Study for Aclidinium and Formoterol
Almirall SA and Forest Laboratories Inc announced positive results from AUGMENT/COPD, the second six-month pivotal phase III clinical trial evaluating the efficacy and safety of investigational fixed dose combinations of aclidinium bromide (LAMA) and formoterol fumarate (LABA) for the treatment of Chronic Obstructive Pulmonary Disease (COPD), delivered in the Pressair inhaler. The 400/12mcg combination of aclidinium/formoterol given twice daily demonstrated improvements in change from baseline for the co-primary endpoints of Forced Expiratory Volume (FEV1) at one hour post-dose versus aclidinium 400mcg (p<0.0001), and morning predose trough FEV1 versus formoterol 12mcg at week 24 (p<0.05). The 400/6mcg combination demonstrated improvements in (FEV1) at one hour post-dose versus aclidinium 400mcg (p<0.0001). For the change from baseline in morning pre-dose trough FEV1, the 400/6mcg combination did not reach significance versus formoterol 12mcg at week 24 (p>0.05). The positive results of the aclidinium/formoterol 400/12mcg combination in the study are consistent with the improvement in lung function demonstrated by aclidinium/formoterol 400/12mcg in the previously completed ACLIFORM/COPD Phase III study. In both studies, the 400/12mcg dose successfully met the required regulatory Combination Rule for testing two or more drugs combined in a single dosage form. Full Article
Forest Laboratories Inc Issues FY 2014 Guidance; Revenue Guidance Below Analysts' Estimates
Forest Laboratories Inc announced that for fiscal 2014, it expects total product sales of approximately $3.3 billion and GAAP diluted earnings per share to be in a range of $0.40 to $0.60. This includes acquisition related amortization and planned research and development milestone payments related to existing pipeline products but does not include any upfront licensing payments which may be made for additional product development transactions or acquisitions that may occur during the fiscal year. Excluding acquisition related amortization non-GAAP earnings per share will be in the range of $0.80 to $1.00. According to I/B/E/S Estimates, analysts were expecting the Company to report revenue of $3.50 billion and EPS of $1.00 for fiscal 2014. Full Article
Almirall SA And Forest Laboratories Inc Announces Positive Phase III Study Results For Aclidinium And Formoterol Combination In COPD
Almirall SA and Forest Laboratories Inc announced positive topline results from a six month pivotal phase III clinical trial evaluating the efficacy and safety of fixed dose combinations of aclidinium bromide, (LAMA) and formoterol fumarate (LABA) delivered by Almirall's inhaler Genuair (Pressair in the USA). Both combinations of aclidinium/formoterol (400/6mcg and 400/12mcg given twice a day) demonstrated statistical improvements in the co-primary endpoints of change from baseline in morning predose trough FEV1 versus formoterol 12mcg and in FEV1 at 1 hour post-dose versus aclidinium 400mcg at week 24 (p <0.01 and p≤0.0001, respectively). In addition, both combinations of aclidinium/formoterol (400/6mcg and 400/12mcg) provided statisticall improvements versus placebo in the above two variables (both p <0.0001). Both fixed-dose combination treatment arms were well tolerated in this study. The common adverse events (greater than or equal to 3% and reported more frequently with aclidinium/formoterol than placebo) were nasopharyngitis (7.9% for 400/6mcg and 7.8% for 400/12mcg fixed-dose combinations and 7.2% for placebo) and back pain (3.4% for 400/6mcg and 4.7% for 400/12mcg fixed-dose combinations and 4.6% for the placebo group). Full Article
Forest Laboratories Inc Sees FY 2013 EPS Guidance At Low End Of Prior Range; Revises FY 2013 Revenue Guidance To A Range In Line With Analysts' Estimates
Forest Laboratories Inc announced that it now expects non-GAAP earnings per share (EPS) for fiscal 2013 will be at the lower end of the previously guided range of $0.45 to $0.60. Total net revenue (includes product sales as well as the earnings contribution from Benicar, authorized generic sales of Lexapro, interest income and other income) is now expected to be between $3.1 billion and $3.2 billion for fiscal 2013. According to I/B/E/S Estimates, analysts were expecting the Company to report EPS of $0.55 on revenues of $3.1 billion for fiscal 2013. Full Article
Glenmark Pharmaceuticals Ltd's Unit inks drug development pact with Forest Laboratories Inc-Business Standard
Business Standard reported that Glenmark Pharmaceuticals Ltd said it has inked an agreement with US-based Forest Laboratories Inc to develop molecules to treat chronic inflammatory conditions. As part of the agreement, Glenmark will receive up to $9 million (around INR50 crore) fromForest Laboratories Inc. The Company's unit, Glenmark Pharmaceuticals SA (GPSA), has entered into an agreement with Forest Laboratories on a collaboration for the development of novel mPGES-1 inhibitors to treat chronic inflammatory conditions, including pain, Glenmark Pharmaceuticals said in a statement. Under the terms of the agreement, Forest will make a $6 million upfront payment to Glenmark and provide an additional $3 million to support the next phase of work. The Mumbai-headquartered firm said Forest would make other future payments in FY14 to support the advancement of the ongoing mPGES-1 inhibitors programme. Full Article
Almirall SA Announces Launch of Tudorza Pressair in United States in Commercialization Agreement with Forest Laboratories Inc
Forest Laboratories (Forest) Inc and Almirall SA announced today that Tudorza Pressair (aclidinium bromide inhalation powder) 400mcg is available in pharmacies throughout the United States. Tudorza is a long-acting anticholinergic recently approved by the United States Food and Drug Administration (FDA) for the long-term, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. Almirall SA granted commercialization rights in the United States for aclidinium to Forest Laboratories Inc. Forest and Almirall will co-promote aclidinium in Canada. Almirall maintains rights for the rest of the world. Full Article
Forest Laboratories Inc Announces Additional Settlement Agreements In BYSTOLIC Patent Litigation
Forest Laboratories Inc announced that they have entered into settlement agreements with Alkem Laboratories, Ltd. (Alkem), Indchemie Health Specialties Pvt. Ltd. (Indchemie), and Torrent Pharmaceuticals Ltd. and Torrent Pharma Inc. (collectively, Torrent) in patent infringement litigation brought by Forest in response to abbreviated new drug applications (ANDAs) filed by Alkem, Indchemie and Torrent each seeking approval to market generic versions of Forest`s BYSTOLIC (nebivolol) tablets. These settlement agreements are in addition to the previously announced Bystolic patent infringement settlement agreement with Hetero Labs Ltd. Specifically, under the terms of the settlement agreements and subject to review of the settlement terms by the U.S. Federal Trade Commission, Forest will provide licenses to each of Alkem, Indchemie and Torrent that will permit these companies to launch their generic versions of BYSTOLIC as of the date that is the later of (a) three calendar months prior to the expiration of U.S. Patent No. 6,545,040, including any extensions and/or pediatric exclusivities or (b) the date each company receives final FDA approval of its ANDA, or earlier in certain circumstances. Full Article
Forest Laboratories Inc And Forest Laboratories Holdings, Ltd. Announces Settlement Agreement With Hetero Labs Ltd. In Bystolic Patent Litigation
Forest Laboratories Inc and Forest Laboratories Holdings, Ltd. announced that they have entered into a settlement agreement with Hetero Labs Ltd. and Hetero USA Inc. (collectively, Hetero) in patent infringement litigation brought by Forest in response to Hetero`s ANDA seeking approval to market generic versions of Forest`s BYSTOLIC (nebivolol) tablets. Specifically, under the terms of the settlement agreement and subject to review of the settlement terms by the U.S. Federal Trade Commission, Forest will provide a license to Hetero that will permit it to launch its generic version of BYSTOLIC as of the date that is the later of three calendar months prior to the expiration of U.S. Patent No. 6,545,040, including any extensions and/or pediatric exclusivities or the date Hetero receives final FDA approval of its ANDA, or earlier in certain circumstances. Full Article
Forest Laboratories Inc Lowers FY 2013 Guidance
Forest Laboratories Inc revised fiscal 2013 guidance and expects total net revenue (includes product sales as well as the earnings contribution from Benicar, authorized generic sales of Lexapro, interest income and other income) is now expected to be $3.2 billion compared with previous guidance of $3.4 billion. The Company expects GAAP earnings per share will be in the range of $0.15 to $0.30 including acquisition related amortization and Non-GAAP earnings per share will be in the range of $0.45 to $0.60 for fiscal 2013. According to I/B/E/S Estimates, analysts were expecting the Company to report EPS of $0.66 on revenues of $3.3 billion for fiscal 2013. Full Article
Forest Labs to add Icahn rep to board, avert proxy fight
- Forest Laboratories Inc said on Tuesday it will add a representative of Carl Icahn as an independent member to its board, averting a new proxy battle with the billionaire investor.
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