On October 28, 2015 Ipsen (Euronext: IPN) (ADR: IPSEY) and Telesta Therapeutics Inc. (TSX: TST) (PNK: BNHLF) reported that they have entered into an exclusive licensing agreement for Ipsen to develop and commercialize MCNA1 for the treatment of high risk non-muscle invasive bladder cancer (NMIBC) in all countries of the world, with the exception of the United States, where Telesta is establishing commercial operations, Canada, South Africa, Mexico, South Korea and Japan (Press release, Ipsen, OCT 28, 2015, View Source [SID:1234507815]). Schedule your 30 min Free 1stOncology Demo! Telesta recently filed a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for MCNA for the treatment of high risk non-muscle invasive bladder cancer patients who are refractory or relapsing from BCG front-line treatment. The FDA has assigned priority review to Telesta’s BLA with a review (PDUFA) date of February 27, 2016. Telesta retains full and sole ownership of MCNA rights in the US and Japan and will be responsible for the commercial launch of MCNA in the United States while Ipsen will initiate discussions with regulatory authorities to identify the regulatory path and potential requirements for the product in Europe and other key licensed territories.
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Commenting on this partnership, Dr. Michael Berendt, Chief Executive Officer and Chief Scientist of Telesta Therapeutics noted: "Ipsen is the ideal commercial partner to bring MCNA to patients in the key pharmaceutical markets outside of the United States. They are a recognized development and commercial leader in the field of uro-oncology and are committed to collaborating with our team to ensure that MCNA is brought forward as rapidly as possible to provide a therapeutic option for this underserved patient population. Their extensive knowledge of the regulatory and commercial landscape, their commercial presence in more than 100 countries across the globe, as well as their commitment to their core urology franchise, particularly bladder cancer, is why we are convinced that they will successfully bring MCNA to urologists and their patients, outside of the United States, and generate significant value for Telesta’s shareholders."
Marc de Garidel, Chairman and Chief Executive Officer of Ipsen stated: "Ipsen is pleased to enter into a partnership with Telesta Therapeutics for Europe and key Rest of the World territories. We believe MCNA, which received priority review from FDA, is a promising second line bladder cancer treatment that would perfectly fit our urology-oncology portfolio in Europe." Marc de Garidel added: "This licensing agreement fits our business development strategy, focusing on selected niche therapeutic areas".
Under the financial terms of the agreement, Telesta is eligible to receive up to US$137 million in upfront and milestone payments comprising a US$10 million upfront payment and additional payments contingent upon achievement of regulatory and sales milestones. In addition, Telesta is eligible to receive meaningful tiered double-digit royalties on net sales of MCNA in the licensed territories.
About MCNA
MCNA is a biologic therapy developed to provide high risk non-muscle invasive bladder cancer patients who are refractory to or relapsing from first line therapy with bacillus Calmette-Guérin (BCG), with a therapeutic alternative to surgery. MCNA is derived from the cell wall fractionation of a non-pathogenic bacteria. Its activity is believed to be through a dual mechanism of immune stimulation and direct anti-cancer effects. MCNA was developed to be delivered as a sterile suspension for intravesical administration by urologists and urology nurses, following the same dosing paradigm as first line BCG therapy, with the advantage that it can be prepared, handled and disposed of easily and safely. The efficacy, duration of response and safety data from MCNA’s pivotal Phase 3 trial was recently published2 in The Journal of Urology. The FDA has set February 27, 2016 as its review goal date for MCNA’s potential approval. MCNA offers a new therapeutic option for high risk NMIBC patients and, if approved, will represent the first new therapeutic approved for these patients in the United States since 1989.
About non-muscle invasive bladder cancer (NMIBC)
Treatment options for high risk NMIBC patients who fail first line BCG treatment are extremely limited and treatment guidelines in most countries around the world call for radical cystectomy, which entails a surgical removal of the bladder and adjacent organs and glands. Bladder removal is a complex surgery associated with at least 28% to 45% surgical complications and up to 8% mortality, in addition to negatively impacting multiple aspects of quality of life. Patients who refuse or are not medically fit to undergo bladder removal face an increased risk of progression to muscle-invasive disease, likely leading to metastases and death.
10-Q – Quarterly report [Sections 13 or 15(d)]
(Filing, 10-Q, Bristol-Myers Squibb, OCT 27, 2015, View Source [SID:1234507811])
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AbCheck Achieves First Milestone in Pierre Fabre Partnership
On October 27, 2015 – AbCheck s.r.o ., a technology company focusing on the discovery and optimization of high – quality human antibodies, reported the achievement of a first milestone in its strategic partnership with Pierre Fabre Pharmaceuticals of Castres, France (Press release, AbCheck, OCT 27, 2015, View Source [SID:SID1234515613]). The milestone represents confirmation of in vivo activity for at least one antibody discovered by AbCheck under the collaboration agreement and triggers an undisclosed miles tone payment from Pierre Fabre.
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AbCheck , a wholly owned subsidiary of Affimed, Heidelberg, Germany, recognized throughout the US and Europe for its expertise in discovering and optimizing human antibodies and Pierre Fabre, France’s third – largest pharmaceutical company with a long – standing commi tment to oncology and immunology, entered into a development collaboration in 2014. This collaboration was expanded into a strategic partnership in June 2015. Under the ongoing agreement, AbCheck uses its proprietary human antibody discovery platform and o ptimization technologies to deliver antibodies against Pierre Fabre’s targets.
"Reaching this first milestone for Pierre Fabre proves the effectiveness of our technology platforms for the efficient discovery of high – quality antibodies," said Dr. Volker La ng, Managing Director of AbCheck. "We have recently added a novel mass humanization technology to our established technologies, which include the proprietary AbSieve and AbAccel platforms."
Novartis Q3 Results 2015
On October 27, 2015 Novartis reported strong core margin expansion (cc) and continued to strengthen the pipeline in Q3; on track for full-year guidance (Press release, Sandoz, OCT 27, 2015, View Source [SID:1234508300]).
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Solid growth (cc[1]) in Q3 sales, core operating income, core EPS for continuing operations[2]
Net sales were USD 12.3 billion (-6%, +6% cc)
Operating income was USD 2.2 billion (-18%, +2% cc)
Core operating income was USD 3.5 billion (-3%, +14% cc)
Core operating income margin improved 2.2 percentage points (cc)
Net income declined mainly due to Q3 provision for conditional settlement in principle of specialty pharmacies case (slightly below USD 0.4 billion)[3] and prior-year gain from sale of Idenix shares
Core EPS was up 14% (cc) to USD 1.27 (-1% USD), and free cash flow[1] was USD 2.8 billion (-11% USD primarily due to currency)
Strong USD negatively impacting sales by -12% and core operating income by -17%
Strong performance of Pharmaceuticals and Sandoz more than offset weakness at Alcon
Alcon growth acceleration plan development underway and will be reflected in 2016 guidance given with 2015 full-year results
Strong innovation momentum and progress on new launches continued in Q3
Entresto received positive CHMP opinion and Swissmedic approval
Tafinlar + Mekinist received EMA approval and FDA priority review in BRAF V600+ melanoma
New data on Cosentyx showed sustained efficacy in psoriasis patients after three years
Progress continued in immuno-oncology with acquisition of Admune Therapeutics (IL-15), licensing agreements with XOMA (TGF-beta) and Palobiofarma (adenosine receptor)
Neuroscience pipeline was strengthened with Amgen partnership for BACE and migraine portfolio; pending acquisition from GSK of ofatumumab rights in multiple sclerosis
Sandoz filing for biosimilar etanercept was accepted by FDA
Growth Products continued to drive Q3 performance and rejuvenate portfolio
Growth Products[4] grew 14% (USD) to USD 4.2 billion, or 34% of net sales
Cosentyx launch off to strong start in US; Entresto approved and launched in US
Outlook 2015 for continuing operations confirmed
Continuing operations net sales expected to grow mid-single digit (cc); core operating income expected to grow ahead of sales at a high-single digit rate (cc)
United Therapeutics Corporation Reports Third Quarter 2015 Financial Results
On October 27, 2015 United Therapeutics Corporation (NASDAQ: UTHR) reported its financial results for the third quarter ended September 30, 2015 (Press release, United Therapeutics, OCT 27, 2015, View Source [SID:1234507917]).
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"We are pleased with our third quarter 2015 results as total revenues reached $386 million and each of our pulmonary arterial hypertension products realized their highest revenue levels ever," said Roger Jeffs, Ph.D., United Therapeutics’ President and Co-Chief Executive Officer. "We are also happy to report the first commercial sales of Unituxin for the treatment of high-risk neuroblastoma. These strong financial results will enable us to continue advancing our innovative product pipeline and returning value to our shareholders through our recently announced $500 million share repurchase program."
Financial Results for the Three Months Ended September 30, 2015
Revenues
Revenues for the three months ended September 30, 2015 increased by $56.3 million, compared to the three months ended September 30, 2014. The growth in revenues primarily resulted from: (1) a $22.6 million increase in Adcirca revenues, driven by price increases, which are determined by Eli Lilly and Company, and by an increase in the number of Adcirca bottles sold; and (2) a $19.9 million increase in Orenitram revenues due to an increase in the number of patients being treated. In addition, $4.7 million of the increase in revenue was due to our first commercial sales of Unituxin, which commenced during the three months ended September 30, 2015.
Expenses
Research and development expense.
Share-based compensation. The decrease in share-based compensation of $113.6 million for the three months ended September 30, 2015, compared to the same three-month period in 2014, was primarily due to a 25 percent decrease in our stock price during the quarter ended September 30, 2015, compared to a 45 percent increase during the same quarter in 2014.
General and administrative. The decrease in general and administrative expense of $12.8 million for the three months ended September 30, 2015, compared to the same three-month period in 2014, resulted from a $13.0 million decrease in grants to non-profit organizations that provide financial assistance to patients with pulmonary arterial hypertension.
Share-based compensation. The decrease in share-based compensation of $208.8 million for the three months ended September 30, 2015, compared to the same three-month period in 2014, was primarily due to a 25 percent decrease in our stock price during the quarter ended September 30, 2015, as compared to a 45 percent increase during the same quarter in 2014.
Cost of product sales. The decrease in cost of product sales for the three months ended September 30, 2015, compared to the three months ended September 30, 2014, was due to the expiration of our royalty obligation to GlaxoSmithKline plc in October 2014. During the three months ended September 30, 2014, we incurred $24.9 million in royalty expense related to this royalty obligation.
Share-based compensation. The decrease in share-based compensation of $16.9 million for the three months ended September 30, 2015, compared to the same three-month period in 2014, was primarily due to a 25 percent decrease in our stock price during the quarter ended September 30, 2015, as compared to a 45 percent increase during the same quarter in 2014.
Gain on Sale of Intangible Asset
In September 2015, we sold the Rare Pediatric Priority Review Voucher (PPRV) we received from the FDA in connection with the approval of our Biologics License Application for Unituxin. In exchange for the voucher, we received $350.0 million from AbbVie Ireland Unlimited Company (AbbVie), a wholly-owned subsidiary of AbbVie Inc. The proceeds from the sale of the PPRV were recognized as a gain on the sale of an intangible asset, as the PPRV did not have a carrying value on our consolidated balance sheet at the time of sale.
Income Tax Expense
The provision for income tax expense is based on an estimated annual effective tax rate that is subject to adjustment in subsequent quarterly periods if components used to estimate the annual effective tax rate are updated or revised. Our estimated annual effective tax rates were approximately 38 percent and approximately 36 percent as of September 30, 2015 and September 30, 2014, respectively. Our 2015 estimated annual effective tax rate increased as of September 30, 2015 primarily due to a decrease in the estimated general business credits as compared to the prior year.
Non-GAAP Earnings
Non-GAAP earnings is defined as net income, adjusted for the following charges, which are presented net of our annual effective income tax rate, as applicable: (1) interest expense; (2) license fees; (3) depreciation and amortization; (4) impairment charges; and (5) share-based compensation expense (stock option, share tracking award and employee stock purchase plan). For 2015, we also adjusted non-GAAP earnings to eliminate the gain (net of our annual effective income tax rate) resulting from the sale of the PPRV in September 2015.