On January 18, 2017 Telix Pharmaceuticals Limited ("Telix") reported a product development partnership with Therapeia GmbH & Co KG ("Therapeia") (Press release, Telix Pharmaceuticals, JAN 18, 2017, View Source [SID1234626270]). Telix will add Therapeia’s ACD-101 theranostic program for glioblastoma to its pipeline of advanced theranostic radiopharmaceutical products. Telix also has secured the option to acquire Therapeia under pre-agreed terms. The financial terms of the transaction are not disclosed.

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ACD-101 is a synthetic amino acid that targets the L-type amino acid transporter 1 (LAT1), which is strongly over-expressed in many aggressive malignancies, including glioblastoma, multiple myeloma, melanoma, gastric, breast, prostate and primary hepatocellular carcinoma (HCC). ACD-101 has been studied clinically with both diagnostic radiolabels (for imaging with Positron Emission Tomography – PET) and therapeutic radionuclides. ACD-101 demonstrates favourable therapeutic biodistribution and kinetics, and is actively transported across the intact blood-brain-barrier into tumour cells. ACD-101 potentially offers therapeutic benefit as a monotherapy, and in conjunction with other therapeutic agents, including radiotherapies (external beam therapy, microspheres, brachytherapy, etc.), due to its radiosensitization effect.

CEO Chris Behrenbruch stated, "ACD-101 is a unique multi-action agent that has the potential to deliver something really new to the management of several very challenging malignancies, particularly glioblastoma. Early patient experience in Germany has demonstrated promising therapeutic results and we are excited to be working with the Therapeia team to take this program forward to Phase II and beyond."

Therapeia Managing Director, Dr. Andreas Kluge added, "We are delighted become part of the Telix team and to add this program to Telix’s stable of theranostic radiopharmaceuticals. The radiopharmaceutical space has lacked commercial critical mass for decades, and has only just started to gain the clinical and product development momentum it truly deserves. Only by building a portfolio of best-in-class products and financing them appropriately, can we expect to see the field deliver on its enormous clinical potential." Dr. Kluge joins Telix as a Co-Founder and Chief Medical Officer.1

About ACD-101

ACD-101 is a synthetic amino acid that targets the L-type amino acid transporter 1 (LAT1), which is over-expressed in many malignancies, including glioblastoma, multiple myeloma and primary hepatocellular carcinoma (HCC). LAT1 forms part of the tumour metabolome, harnessed by tumour cells to grow at the expense of surrounding healthy cells. LAT1 has been recently identified as promising drug target in oncology. Over a hundred patients have been successfully imaged with ACD-101 to study biodistribution and kinetics, including in patients with inoperable brain tumours. Clinical pilot studies for the therapeutic forms of ACD-101 have commenced in Europe.

In glioma, ACD-101 is actively transported over the intact blood-brain-barrier into tumour cells overexpressing LAT1, conveying a unique triple mode of action consisting of 1) a targeted radiation toxicity, when administering radiolabeled forms of ACD-101 (131I, 211At), 2) a direct cytostatic effect combined with 3) an intrinsic radiosensitizer effect, enhancing the activity of both, internal and external radiation therapy. The fact, that pathologically increased amino acid uptake is central function in any tumour disease, suggests that ACD-101 may have very broad clinical applicability.

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 Cancer Research UK, Cancer Research Technology and MRC Technology reported that they are joining forces to identify and validate novel drug discovery targets that could lead to new immunotherapy treatments (Press release, Cancer Research Technology, 18 18, 2017, View Source [SID1234523172]).

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The partnership brings together Cancer Research UK’s network of leading scientists with CRT’s cancer-focused target selection and validation expertise, and MRCT’s antibody screening and development capability. The collaboration will identify possible targets for the development of both antibody and small molecule therapeutics. The next stage of the collaboration will be to seek a clinical partner to accelerate the progress of promising compounds into the clinic.

New targets that increase cancer’s susceptibility to the immune system will be identified from Cancer Research UK’s funded research. MRC Technology will develop antibodies for suitable targets via its antibody screening platform, while CRT will focus on small molecule approaches.

Dr Hamish Ryder, director of discovery, Cancer Research Technology, said: "Immunotherapy is a hugely promising approach to cancer treatment and we’re delighted to extend our research in this area by partnering with MRC Technology.

"The aim of this alliance is to work together to identify highly novel immunotherapy targets and develop treatments that will complement the checkpoint inhibitors that are already having such an impact on patients.

"We want to move quickly to bring promising new drugs forward to treat cancer patients as soon as possible."

Dr Justin Bryans, director, drug discovery at MRC Technology said: "Bringing together MRC Technology’s antibody drug discovery and CRT’s cancer biology expertise and applying them to cutting-edge discoveries from the Cancer Research UK network represents a very exciting prospect and will help us identify and develop new immune-oncology therapies, which already have a significant impact on cancer patients’ lives."

CRT and MRC Technology will be joint commercialisation partners for the collaboration and any resulting immunotherapy treatments.

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 Takara Bio USA Holdings, Inc. ("TBUSH") reported that it has completed the acquisition of Rubicon Genomics, Inc. ("Rubicon"), Rubicon has become a wholly-owned subsidiary of TBUSH as of January 17, 2017 (US local time) (Press release, Takara Bio, JAN 17, 2017, View Source [SID1234517461]).

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Under the merger agreement executed with Rubicon, TBUSH paid 75 million US dollars to acquire 100% of the equity in Rubicon. TBUSH is a wholly owned subsidiary of Takara Bio Inc. ("Takara Bio"), a leading global biotechnology and life science company headquartered in Shiga, Japan. Takara Bio USA, Inc. ("TBUSA", formerly known as Clontech Laboratories, Inc.) is a wholly owned subsidiary of TBUSH, and both TBUSA and TBUSH are part of the global Takara Bio Group. The impact of the acquisition on Takara Bio Inc.’s financial results in 2017 will be immaterial.

The Takara Bio Group provides a wide range of life science products and services under the Takara, Clontech, and Cellartis brands that assist discovery, translational, and clinical scientists in the advancement of their work. The Rubicon acquisition will allow the Takara Bio Group to augment and expand its worldwide commercial offerings in next generation sequencing (NGS) sample preparation and expand into new markets.

"We are pleased to announce the completion of this transaction and officially welcome Rubicon to the Takara Bio Group," said Carol Lou, President, TBUSA. "We are excited about the synergy between Rubicon’s technologies and products and our own longstanding expertise and SMART-based portfolio of cDNA synthesis, low-input, and single cell RNA-seq products. We now have an expanded NGS and genetic analysis capabilities that strengthen our product portfolio and allow us to better serve the life science research market, as well as creating new opportunities for us to serve customers in IVF and other clinical markets. We are excited to move forward as one organization positioned for growth."

As previously communicated, Rubicon’s technology is also complementary with the WaferGen Bio-systems, Inc. instrument platforms and technologies. TBUSH announced plans to acquire WaferGen in 2016, and anticipates that the merger will close in March 2017. The combined acquisitions are synergistic and will allow the Takara Bio Group to provide the exciting benefits of the combined portfolios to the life science community.