May. 27, 2014, 4:52 PM
- Actavis (ACT +0.3%) files an ANDA for a generic version of AstraZeneca (AZN -0.3%) and Bristol-Myers Squibb's (BMY +0.2%) Onglyza (saxagliptin hydrochloride), a treatment for glycemic control in adults with type 2 diabetes.
- AZN filed suit against ACT on May 23, 2014 to prevent it from commercializing its generic version prior to the expiration of the '400 patent. The court instituted a stay of final FDA approval of the ANDA until January 31, 2017 or final resolution of the suit, whichever occurs sooner. ACT believes it is the first filer so it will be entitled to 180 days of generic market exclusivity upon regulatory clearance.
- According to IMS Health Data, U.S. Onglyza sales were ~$532M for the 12-month period ending February 28, 2014.
May. 15, 2014, 9:32 AM
- Actavis (ACT) and J&J (JNJ) unit Janseen Pharmaceuticals extend their supply and distribution agreement for Janssen's Concerta (methylphenidate hydrochloride extended-release tablets) to December 31, 2017. Janssen will continue to manufacture and supply all dosage strengths of the authorized generic product and Actavis will continue to market it in the U.S. and pay Janssen 50% of net sales.
- Under the terms of the contract, Actavis may pursue FDA clearance of its own ANDA for a generic version of the product and launch it at after 2017.
May. 15, 2014, 8:56 AM
- The English High Court has ruled that Actavis' (ACT) generic version of Eli Lilly's (LLY) blockbuster lung-cancer drug Alimta doesn't breach the latter company's dosage patents if Actavis sells certain alternative salt forms of the drug when its compound IP ends in 2015.
- The court granted corresponding declarations of non-infringement regarding patents on Alimta's vitamin dosage regimen in France, Italy and Spain.
- The U.K. court's ruling is contrast to the verdict of a regional court in Germany that backed Lilly on the IP. The U.S. company has other U.K. patents on the drug that are due to last till 2021.
May. 14, 2014, 9:56 AM
- Actavis (ACT -0.4%) will reshuffle its executive team after its acquisition of Forest Labs (FRX -0.3%) closes. Actavis Chairman and CEO Paul Bisaro will become Executive Chairman, Forest President and CEO Brent Saunders will become CEO and President reporting to Mr. Bisaro and Actavis Global Operations President Robert Stewart will become COO reporting to Mr. Saunders.
May. 12, 2014, 8:26 AM
- Actavis (ACT) and Valeant Pharmaceuticals (VRX) settle their patent suit over Actavis' generic Acanya (clindamycin phosphate and benzoyl peroxide) Gel for the treatment of acne vulgaris.
- Under the terms of the agreement Valeant grants Actavis a license to manufacture a generic version effective July 1, 2018 or earlier under certain circumstances and contingent upon the FDA clearance of ACT's ANDA.
- According to IMS Health, Acanya generated $121M in sales over the 12-month period ending February 28, 2014.
Apr. 30, 2014, 2:55 PM
- Shares of Avanir Pharmaceuticals (AVNR +39.5%) pop on slightly higher volume after the Delaware District Court rules that Actavis' generic product specified in its ANDA infringes on Nuedexta's '282 and '484 patents, but not the '115 patent. The court also upheld the validity of the three patents.
- The two firms signed a settlement agreement on the matter eight months ago whereby Actavis (ACT +3.6%) would have the right to sell a generic version beginning July 30, 2026.
Apr. 30, 2014, 9:17 AM
- Net revenues: $2.66B (+40%).
- EPS: $0.55 (-30.4%).
- CF Ops: $440M (+101.3%).
- Updated 2014 guidance:
- Financial forecast including Forest Labs (FRX) will be made mid-year after the transaction closes.
- Q2 non-GAAP earnings will be slightly lower than Q1.
- Standalone forecast made on January 31 should be considered withdrawn.
Apr. 30, 2014, 7:07 AM
Apr. 29, 2014, 5:30 PM
- AB, ABX, ACCO, ACT, ADP, ADT, ALLT, AUDC, AUO, CEVA, CKSW, CVE, D, DHX, ENR, EVER, EXC, GIB, GOV, GRMN, GVA, H, HES, HPY, HSP, IACI, ICON, IMN, INGR, IP, ISSI, JLL, LL, LVLT, MGAM, MRGE, MSCI, MWV, NEE, NI, NVMI, NYCB, OMG, OSIS, PBI, PNK, PSX, PSXP, RDWR, RGS, SEE, SNCR, SO, SPW, SUI, TASR, TFX, TRI, TWX, TX, WEC, WLP, ZEUS.
Apr. 29, 2014, 7:35 AM
- Taking exception to the FDA's decision to award exclusive rights to Teva Pharmaceutical Industries (TEVA) to sell a generic version of Pfizer's (PFE) Celebrex, Actavis (ACT) sues the regulator. The company's action follows Mylan's (MYL) suit filed on Friday.
- The company believes the agency acted improperly when it awarded exclusivity to Teva despite a ruling from the U.S. Court of Appeals for the Federal Circuit that resulted in the expiration of that entitlement.
- The Celebrex patent will expire in May. Teva plans to launch its generic version in December.
- Celebrex generated almost $3B in sales in 2013 according to Pfizer.
Apr. 28, 2014, 7:58 AM
- Forest Laboratories (FRX) has agreed to acquire Furiex Pharmaceuticals (FURX) for $1.1B in cash in a deal that Forest says will enable it to strengthen its position in Gastroenterology.
- Forest, which is being bought by Actavis (ACT) is offering $95 a share vs Furiex's close of $80.15 on Friday.
- Forest has also proposed up to $30 a share ($360M) in a Contingent Value Right (CVR) that may be payable based on the status of eluxadoline, Furiex's lead product, as a controlled drug following approval
- Forest has also agreed to sell Furiex's royalties on alogliptin and Priligy to Royalty Pharma for $415M once Forest has bought Furiex.
- Furiex's shares are +28.51%. (PR)
Apr. 21, 2014, 5:24 PM
Apr. 17, 2014, 4:44 PM
- Actavis (ACT) buys four currently-marketed products from Akorn (AKRX) and one more under development for cash. The transaction is contingent on the consummation of Akorn's acquisition of Hi-Tech Pharmacal (HITK).
- The products on the market are: Ciprofloxacin Hydrochloride Ophthalmic Solution, Levofloxacin Ophthalmic Solution, Lidocaine Hydrochloride Jelly and Lidocaine/Prilocaine Topical Cream.
- The FTC stipulated that Akorn divest the products as a condition of its approval of the Hi-Tech transaction.
- Financial terms are not disclosed.
Apr. 14, 2014, 8:43 AM
- Depomed (DEPO) settles with two of three defendants in the Gralise (gabapentin) patent infringement litigation. Incepta Pharmaceuticals and Zydus Pharmaceuticals may market generic versions of the 300 mg and 600 mg tablets on January 1, 2024 or earlier contingent on certain circumstances.
- Litigation continues with the third defendant Actavis (ACT).
Apr. 1, 2014, 9:50 AM
- Actavis (ACT) pays $100M cash for generic drug maker Silom Medical Company, a private firm focused on the Thai market.
- Silom has a leading position in ophthalmology and respiratory therapy as well as a strong presence in cardiovascular disease. It offers more than 25 products to more than 4,400 hospitals, clinics and drugstores in Thailand.
Mar. 31, 2014, 7:49 AM
- Forest Labs (FRX) and Gedeon Richter (GEDSF) have announced positive top-line results in a Phase II trial of the companies' Cariprazine therapy for the treatment of bipolar depression.
- The results come after Cariprazine also performed well in a Phase IIb trial for patients with Major Depressive Disorder. (PR)
- Forest is being acquired by Actavis (ACT).
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