|May 12, 2014|
|07:54 EDT||GSK, LCI||Lannett announces multi-services agreement with Sunshine Lake|
Lannett Company (LCI) announced that it has entered into distribution and contract manufacturing services agreements with Sunshine Lake LLC, the U.S. subsidiary of the HEC Pharm Group of Shenzhen, Guangdong Province, China. Under terms of the distribution agreement, Lannett will be the exclusive distributor in the U.S. for Sunshine Lake’s Zidovudine generic pharmaceutical product in finished dosage form. Zidovudine Tablets 300 mg was launched by Lannett last week. According to IMS, full year 2013 total sales of Zidovudine Tablets 300 mg, the generic equivalent of Retrovir, a registered trademark of GlaxoSmithKline (GSK), at Average Wholesale Price were approximately $4.5M. The intention of the parties is to add additional products from time to time, and may include a number of ANDAs currently pending at FDA, as well as future filings.
News For LCI;GSK From The Last 14 Days
|September 3, 2015|
|12:23 EDT||LCI||On The Fly: Top stock stories at midday|
Subscribe for More Information
|09:04 EDT||LCI||Lannett acquisition positive, says Roth Capital|
After Lannett (LCI) agreed to buy Kremers Urban Pharmaceuticals, Roth Capital says that the deal could potentially double Lannett's revenue base and lift its EPS by 20%-25% in 2017. The firm says that Kremers could surpass Lannett's guidance if the FDA switches its rating on Kremer's Methylphenidate drug to AB from BX. The firm notes that the agency is considering such a change. Roth raised its price target on the name to $68 from $64 and reiterates a Buy rating.
|07:50 EDT||LCI||Lannett acquisition provides 'much needed jolt,' says Oppenheimer|
Subscribe for More Information
|September 2, 2015|
|18:39 EDT||LCI||On The Fly: After Hours Movers |
UP AFTER EARNINGS: SeaChange (SEAC), up 4.5%... Planet Fitness (PLNT), up 7.1%. ALSO HIGHER: Geron (GERN), up 19.7% after publishing two papers in The New England Journal of Medicine... Lannett (LCI), up 16.6% after announcing that it will acquire Kremers Urban. DOWN AFTER EARNINGS: Five Below (FIVE), down 9.3%... Verint Systems (VRNT), down 6.1%... Catalent (CTLT), down 4.9%.
|16:36 EDT||LCI||Lannett up 9.1% after announcing that it will acquire Kremers Urban |
|16:35 EDT||LCI||Lannett to acquire Kremers Urban Pharmaceuticals For $1.23B|
Subscribe for More Information
|16:34 EDT||LCI||Lannett to acquire Kremers Urban Pharmaceuticals For $1.23B|
|12:46 EDT||GSK||GlaxoSmithKline reports 24.5% passive stake in Theravance Biopharma |
Subscribe for More Information
|September 1, 2015|
|07:34 EDT||GSK||Adaptimmune expands trial of T-cell therapy for synovial sarcoma|
Adaptimmune Therapeutics (ADAP) announced that the first patient has been dosed in its expanded Phase I/II trial of its affinity enhanced T-cell receptor therapeutic targeting the NY-ESO-1 cancer antigen in synovial sarcoma patients. Based on encouraging results in the first cohort of 10 patients, presented at the American Association for Cancer Research annual meeting in April 2015, the trial is being expanded to encompass an additional 20 patients in two further cohorts. The expansion of Adaptimmune's trial also triggers two milestone payments from GlaxoSmithKline (GSK). Adaptimmune is collaborating with GSK for the development of its NY-ESO TCR program through a strategic cancer immunotherapy partnership announced in June 2014. Under the terms of the agreement, GSK has an exclusive option to license Adaptimmune's NY-ESO TCR therapeutic and upon exercise would assume full responsibility for further development and commercialization of the therapeutic. Adaptimmune's clinical study includes synovial sarcoma patients who have received standard first line therapy containing ifosfamide and/or doxorubicin and who are intolerant or no longer responding to the regimen, and whose tumor expresses a tumor antigen known as NY-ESO-1. The NY-ESO-1 antigen is believed to be present in 60 to 70 percent of synovial sarcoma patients.The primary objectives of the study are to determine the safety of adoptively transferred autologous T cells expressing an affinity enhanced T cell receptor that recognizes the NY-ESO-1 antigen in HLA-A*0201, HLA-A*0205, and/or HLA-A*0206 positive patients with unresectable, metastatic or recurrent synovial sarcoma. Secondary objectives include the determination of efficacy through response rate and duration of response.
|August 26, 2015|
|17:06 EDT||GSK||Gilead AMBITION study results published in New England Journal of Medicine |
Gilead Sciences (GILD) announced detailed results from the AMBITION study. In AMBITION, conducted in collaboration with GlaxoSmithKline (GSK), combination therapy with Letairis and tadalafil reduced the risk of clinical failure by 50% compared to the pooled Letairis and tadalafil monotherapy arm. These data were published in The New England Journal of Medicine. Letairis, a selective endothelin type-A receptor antagonist, and tadalafil, a PDE5 inhibitor, are each approved in the United States, the European Union and other countries as once-daily treatments for patients with pulmonary arterial hypertension with WHO/NYHA functional class II and III symptoms. Letairis is indicated in the U.S. to improve exercise ability and delay clinical worsening and in the EU under the tradename Volibris to improve exercise capacity. Tadalafil 40 mg is indicated in the U.S. and the EU to improve exercise ability and capacity, respectively. Preclinical data have suggested these therapies may have synergistic effects. However, combination use with Letairis and tadalafil is currently not approved.
|08:44 EDT||LCI||Lannett steady execution offers compelling upside, says Susquehanna|
Susquehanna noted Lannett delivered solid Q2 results and outlook and believes its stock price is undervaluing the upside potential from new products and business development. The firm also sees the potential for multiple expansion if volume trends remain steady. Susquehanna reiterated its Positive rating but lowered its price target to $70 from $75 on Lannett shares.
|August 25, 2015|
|16:08 EDT||LCI||Lannett sees FY16 CapEx $60M-$70M|
Which includes $30M to continue the partial fit-out of company-owned buildings. Sees FY16 gross margin as a percentage of net sales of approximately 71%-73%; R&D expense in the range of $33M-$35M; SG&A expense ranging from $57M-$59M, which includes approximately $5M in acquisition-related expenses; The full year effective tax rate to be in the range of 34%-35%.
|16:06 EDT||LCI||Lannett sees FY16 revenue $425M-$435M, consensus $433.55M|
|16:05 EDT||LCI||Lannett reports Q4 EPS 91c, consensus 86c|
Reports Q4 revenue $99.3M, consensus $97.62M.
|August 24, 2015|
|13:15 EDT||GSK||FDA expands use of Novartis' Promacta to include children ages 1 and older|
Ligand Pharmaceuticals (LGND) announced that the FDA has approved an expanded use for Promacta, a Novartis (NVS) product, to include children 1 year of age and older with chronic immune thrombocytopenia who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. Promacta was acquired by Novartis in March from GlaxoSmithKline (GSK). Promacta was discovered as a result of research collaboration between GSK and Ligand Pharmaceuticals and was developed by GSK. The updated label also includes a new oral suspension formulation of Promacta that is designed for younger children who may not be able to swallow tablets. Promacta was approved by the FDA as a tablet formulation in June 2015 for children 6 years of age and older and in 2008 for use in adult patients with the same condition. The label expansion of Promacta was based on data from two double-blind, placebo-controlled trials, including the largest Phase 3 clinical trial in this patient population. Treatment with Promacta significantly increased and sustained platelet counts among pediatric patients with chronic ITP with an insufficient response to prior chronic ITP therapies, and some patients taking concomitant ITP medications were able to reduce or discontinue their use of these medications, primarily corticosteroids. Promacta should be used only in those whose degree of thrombocytopenia and clinical condition increase the risk for bleeding.
|August 21, 2015|
|05:25 EDT||GSK||Novartis acquires all remaining rights to Ofatumumab from GSK |
Novartis (NVS) announced that it has entered into an agreement to acquire all remaining rights to Ofatumumab from GlaxoSmithKline (GSK). Ofatumumab, a fully human monoclonal antibody which targets CD20, is being developed for relapsing remitting multiple sclerosis, or RRMS, and other autoimmune indications. Novartis previously acquired the rights to Ofatumumab for oncology indications and it is marketed under the brand name Arzerra. Novartis will be responsible for the worldwide development, regulatory and commercialization activities for Ofatumumab. Under the terms of the agreement, Novartis will make an initial upfront payment of $300M to GSK for the acquisition of the compound and a further payment of $200M payable following the start of a phase III study in MS by Novartis. Upon completion of pre-determined milestones, contingent payments of up to $534M may be made. Novartis will also pay royalties of up to 12% to GSK on any future net sales of Ofatumumab in autoimmune conditions.