On January 18, 2017 Eli Lilly says it will spend nearly $1 billion to buy out CoLucid Pharmaceuticals and get its hands on its late-stage acute migraine candidate, which Lilly outlicensed to the company back in 2005 (Press release, FierceBiotech, JAN 18, 2017, View Source [SID1234517455]).

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The all-cash transaction works out to $46.50 a share, after trading at $34.90 at end of play yesterday.
Lilly said in a statement that this will "enhance its existing portfolio in pain management for migraine," while also adding a potential near-term launch to its late-stage pipeline.

This drug, lasmiditan, is an oral 5-HT1F agonist and has already finished the first of two pivotal phase 3 trials.
A data readout for the second test, known as SPARTAN, is expected in the second half of 2017. "If this trial is positive, submission of lasmiditan for U.S. regulatory approval could occur in 2018," the pair say.

Lasmiditan was originally discovered at Lilly and was outlicensed to CoLucid 12 years ago. "At the time lasmiditan was out-licensed, pain management was not a strategic area of focus for Lilly," the company said, but added that it has "since reorganized its research and development efforts to focus on migraine as part of its emerging therapeutic area of pain."

The Big Pharma figures that as many as 36 million people suffer from migraine in the U.S. and sees lasmiditan, if approved, as being a first-in-class therapy to treat migraine through a new mechanism of action, and without vasoconstriction.

"This could be desirable in migraine patients who have, or are at risk for, cardiovascular disease, as well as those who are dissatisfied with their current therapies," it notes.

This bulks out Lilly’s pain pipeline, which includes galcanezumab, currently in phase 3 to help stop migraines and cluster headaches.

And there’s tanezumab, which is being studied in partnership with Pfizer, for the treatment of multiple pain indications, including osteoarthritis, lower back and cancer pain.

"We are excited that lasmiditan will be back at Lilly, where it was originally discovered, for the conclusion of phase 3 development and potential commercialization," said Thomas Mathers, CoLucid’s CEO. "We are proud of the work that CoLucid has done to develop lasmiditan, and we believe Lilly’s expertise in pain and commitment to innovation are a natural fit to potentially bring this medicine to patients."

CoLucid went public with a $55 million IPO in 2015 at $10 per share, with major venture investors including Care Capital, Novo A/S, Domain Partners, TVM Life Science Ventures and Trialthlon Medical Ventures, as well as Pappas Ventures, which founded the company back in 2005.

In the more than 2,200-patient phase 3 SAMURAI study, posted last year, the drug met the primary endpoint of efficacy for low-dose and high-dose lasmiditan versus placebo based on migraine headache pain two hours after dosing. It also met the secondary endpoint of freedom from the most bothersome migraine symptom two hours after dosing.

The second 2,200-plus patient pivotal trial, SPARTAN, is evaluating three doses, with an additional lower-dose arm but with the same primary and secondary endpoints as the SAMURAI trial. It’s expected to examine a patient subgroup of those with cardiovascular risk factors, stable cardiovascular disease or known coronary artery disease.

On January 18, 2017 Eli Lilly and Company and CoLucid Pharmaceuticals, Inc. reported an agreement for Lilly to acquire CoLucid for $46.50 per share or approximately $960 million (Press release, Eli Lilly, JAN 18, 2017, View Source [SID1234517451]). This all-cash transaction will enhance Lilly’s existing portfolio in pain management for migraine, while adding a potential near-term launch to its late-stage pipeline.

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CoLucid Pharmaceuticals is a public biopharmaceutical company developing an oral 5-HT1F agonist (lasmiditan) for the acute treatment of migraine. CoLucid has completed the first of two pivotal Phase 3 trials. A data read-out for the second Phase 3 trial, SPARTAN, is expected in the second half of 2017. If this trial is positive, submission of lasmiditan for U.S. regulatory approval could occur in 2018.

More than 36 million people suffer from migraine in the United States alone. Lasmiditan, if approved, would be a first-in-class therapy to treat migraine through a novel mechanism of action without vasoconstriction. This could be desirable in migraine patients who have, or are at risk for, cardiovascular disease, as well as those who are dissatisfied with their current therapies.

Lasmiditan is an important addition to Lilly’s emerging pain management pipeline, which includes galcanezumab, a potential medicine in Phase 3 clinical development for the prevention of migraine and cluster headache. In addition, tanezumab is being studied, in collaboration with Pfizer, for the treatment of multiple pain indications, including osteoarthritis, lower back and cancer pain.

"Lasmiditan is a novel, first-in-class molecule that could represent the first significant innovation for the acute treatment of migraine in more than 20 years, and CoLucid has made significant progress in advancing this potential medicine," said David A. Ricks, Lilly’s president and chief executive officer. "This innovation, along with galcanezumab, could offer important options for the millions of patients suffering from migraine."

Lasmiditan was originally discovered at Lilly and was out-licensed to CoLucid in 2005. Over the past 12 years, CoLucid has taken important steps to decrease the risk related to development and commercialization of lasmiditan as evident by the first positive Phase 3 trial. At the time lasmiditan was out-licensed, pain management was not a strategic area of focus for Lilly. Lilly has since reorganized its research and development efforts to focus on migraine as part of its emerging therapeutic area of pain.

"We are excited that lasmiditan will be back at Lilly, where it was originally discovered, for the conclusion of Phase 3 development and potential commercialization," said Thomas P. Mathers, CoLucid’s chief executive officer. "We are proud of the work that CoLucid has done to develop lasmiditan, and we believe Lilly’s expertise in pain and commitment to innovation are a natural fit to potentially bring this medicine to patients."

Under the terms of the agreement, Lilly will acquire all shares of CoLucid Pharmaceuticals for a purchase price of $46.50 per share or approximately $960 million. The transaction is expected to close by the end of the first quarter of 2017, subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act and other customary closing conditions.

While the financial charge will not be finalized until after completion of the acquisition, Lilly is expecting to recognize a financial charge of approximately $850 million (no tax benefit), or approximately $0.80 per share, as an acquired in-process research and development charge to earnings in the first quarter of 2017. The company’s reported earnings per share guidance in 2017 is expected to be reduced by the amount of the charge. There will be no change to the company’s non-GAAP earnings per share guidance as a result of this transaction.

Goldman, Sachs & Co. is acting as the exclusive financial advisor, and Weil, Gotshal & Manges LLP is acting as legal advisor to Lilly in this transaction. MTS Health Partners is acting as the exclusive financial advisor, and Faegre Baker Daniels LLP is acting as legal advisor to CoLucid.

On January 18, 2017 Oncoinvent reported that US Patent 9,539,346 entitled "Radiotherapeutic particles and suspensions" has issued (Press release, Oncoinvent, JAN 18, 2017, http://www.oncoinvent.com/pdf.cfm?dok_id=481 [SID1234517439]). The patent relates to a particle or pharmaceutical composition comprising one or more particles, or a suspension of same or different particles comprising a degradable compound and an alpha emitting radionuclide and/or a radionuclide generating alpha emitting daughter. The particles are beneficial for use in the treatment of cancer.

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Jan A. Alfheim, Oncoinvent’s CEO commented: "This is a significant milestone in the development of our lead product candidate, Radspherin. With this first patent we have gained a solid protection of Radspherin until 2035 in what we believe will be a very significant future market for the product. Our Radspherin patent applications include claims on composition of matter as well as various medical and medical device applications. The current applications and this issued patent are therefore very broad and cover a wide spectrum of Radspherin particle variants and applications."

About Radspherin

Radspherin is a novel alpha-emitting radioactive microsphere designed for treatment of metastatic cancers in body cavities. The radium based therapeutic, Radspherin has shown strong and consistent anticancer activity at doses being essentially non-toxic in preclinical studies. It is anticipated that the product can potentially treat several forms of metastatic cancer. The first clinical indication for Radspherin will be treatment of peritoneal carcinomatosis originating from ovarian cancer. Peritoneal carcinomatosis is one of the most serious complications of gastrointestinal and gynecological malignancies.

On Jan 18, 2017 Delcath Systems, Inc. (NASDAQ: DCTH), an interventional oncology Company focused on the treatment of primary and metastatic liver cancers, reported that new data from a retrospective study of Melphalan/HDS, entitled "Percutaneous Hepatic Perfusion For Unresectable Metastatic Ocular Melanoma To The Liver: A Multi-Institutional Report Of Outcomes," has been accepted for oral presentation at the Regional Cancer Therapies 12th International Symposium, taking place February 18 – 20, 2017 at the Snowbird Ski and Summer Resort in Snowbird, UT (Press release, Delcath Systems, JAN 18, 2017, View Source;p=RssLanding&cat=news&id=2238088 [SID1234517438]).

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The retrospective study was conducted by teams from Moffitt Cancer Center in Tampa, FL and the University of Southampton in the United Kingdom. The study explores patient treatment outcomes with Percutaneous Hepatic Perfusion (PHP Therapy) with Melphalan/HDS in patients with primary metastatic ocular melanoma (OM) with liver metastasis treated between 2008 and 2016. The study was led by Dr. Alexandra Gangi of the Moffitt Cancer Center.

"We are very pleased that Dr. Gangi and her team’s research has been accepted for oral presentation at this prestigious event and believe that their research results will further inform on the use of Melphalan/HDS as a potentially viable additional option for treatment of hepatic metastases in patients with metastatic ocular melanoma," said Jennifer K. Simpson, Ph.D., MSN, CRNP, President and Chief Executive Officer of Delcath. "We look forward to announcing the details of these new data after they are presented."

On January 18, 2017 Celsion Corporation (NASDAQ:CLSN), a clinical stage oncology drug development company, reported that the United States Patent and Trademark Office has granted U.S Utility Patent No. 9,492,385 B2 – Temperature-Sensitive Liposomal Formulation, which is directly applicable to the method of treating cancer using the Company’s current ThermoDox formulation (Press release, Celsion, JAN 18, 2017, View Source [SID1234517437]). The claims cover intravenous or direct (to the tumor) administration of the formulation followed by heating and extends coverage time over ThermoDox’s current parent patents. The Company also announced the issuance of Korean Patent No. 1652126 – Novel Thermosensitive Liposomes Containing Therapeutic Agents, which relates to composition claims directed to a thermally sensitive liposome that contains all of the components in the Company’s ThermoDox liposome as well as one additional lipid (DSPG).

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These two new patents strengthen the global coverage of ThermoDox, Celsion’s proprietary dose form of doxorubicin based on a heat-activated liposomal platform technology, currently in Phase III development for the treatment of primary liver cancer, also known as hepatocellular carcinoma (HCC). The Company’s Phase III OPTIMA Study is expected to enroll up to 550 patients at up to 75 clinical sites in the North America, Europe, China, S. Korea, Taiwan, and Southeast Asia, and will evaluate ThermoDox in combination with optimized RFA, which will be standardized to a minimum of 45 minutes across all investigators and clinical sites for treating HCC lesions three to seven centimeters, versus standardized RFA alone.

"The issuance of these patents further strengthens Celsion’s growing position as a leader in the development of directed chemotherapeutics designed to address some of the most difficult-to-treat cancers. In conjunction with its composition of matter patents, these new issuances broaden our intellectual property portfolio and provides for life cycle management of ThermoDox well into the next decade. Additionally by covering the use of ThermoDox, Celsion reinforces its exclusivity in many of the major markets around the world where HCC approaches epidemic proportions," said Michael H. Tardugno, chairman, president and CEO. "HCC has the fastest rate of growth of all cancers with annual incidence of over 800,000 new cases and is projected to be the most prevalent form of cancer by 2020."

ThermoDox is currently in late stage clinical trials in primary liver cancer and recurrent chest wall breast cancer. It is positioned for use with multiple heating technologies, and has the potential for applications in the treatment of other forms of cancer including metastatic liver and non-muscle invading bladder cancers.

About ThermoDox
Celsion’s most advanced program is a heat-mediated drug delivery technology that employs a novel heat-sensitive liposome engineered to address a range of difficult-to-treat cancers. The first application of this platform is ThermoDox, a lyso-thermosensitive liposomal doxorubicin (LTLD), whose novel mechanism of action delivers high concentrations of doxorubicin to a region targeted with the application of localized heat at 40°C, just above body temperature. ThermoDox has the potential to address a broad range of cancers.

Celsion’s LTLD technology leverages two mechanisms of tumor biology to deliver higher concentrations of drug directly to the tumor site. In the first mechanism, rapidly growing tumors have leaky vasculature, which is permeable to liposomes and enables their accumulation within tumors. Leaky vasculature influences a number of factors within the tumor, including the access of therapeutic agents to tumor cells. Administered intravenously, ThermoDox is engineered with a half-life to allow significant accumulation of liposomes at the tumor site as these liposomes recirculate in the blood stream. In the second mechanism, when an external heating device heats tumor tissue to a temperature of 40°C or greater, the heat-sensitive liposome rapidly changes structure and the liposomal membrane selectively dissolves, creating openings that can release a chemotherapeutic agent directly into the tumor and into the surrounding vasculature. Drug concentration increases as a function of the accumulation of liposomes at the tumor site, but only where the heat is present. This method damages only the tumor and the area related to tumor invasion, supporting more precise drug targeting.