On February 25, 2021 InDex Pharmaceuticals Holding AB (publ) reported that year-end report 2020 (Press release, InDex Pharmaceuticals, FEB 25, 2021, View Source [SID1234575589]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Financing secured for phase III development of cobitolimod

"With the equity financing secured until the next pivotal read-out of clinical data, it feels very inspiring to now advance cobitolimod into phase III, which is the final stage of development before application for market approval," says Peter Zerhouni, CEO of InDex Pharmaceuticals.

Period October – December 2020
Net sales amounted to SEK 0.0 (0.0) million
Operating loss amounted to SEK –10.1 (–25.6) million
Result after tax amounted to SEK –10.1 (–25.6) million, corresponding to SEK –0.04 per share (–0.11) before and after dilution
Cash flow from operating activities amounted to SEK –8.1 (–34.2) million
Period January – December 2020
Revenues amounted to SEK 0.0 (0.1) million
Operating result amounted to SEK –57.3 (–87.7) million
Result after tax amounted to SEK –57.4 (–87.8) million, corresponding to SEK –0.24 per share (–0.45) before and after dilution
Cash flow from operating activities amounted to SEK –70.7 (–85.1) million
Cash and cash equivalents at the end of the period amounted to SEK 53.8 (126.8) million
Number of employees at the end of the period was 7 (7)
Number of shares at the end of the period was 88 781 275
All comparative amounts in brackets refer to the outcome during the corresponding period 2019.

Significant events during October – December 2020
InDex announced the intention to carry out a fully guaranteed rights issue of approximately SEK 500 million to fund phase III development of cobitolimod
Significant events after the reporting period
An extraordinary general meeting was held in InDex on January 12, 2021
The Board of Directors of InDex resolved on a fully guaranteed rights issue of approximately SEK 533 million
InDex published a prospectus in connection with the fully guaranteed rights issue
InDex’s rights issue was oversubscribed and the company received approximately SEK 488 million net
Other events
The Lancet Gastroenterology & Hepatology published the results of InDex’s phase IIb study CONDUCT with cobitolimod and a positive independent expert commentary
InDex hosted a virtual R&D day for investors, analysts and media
CEO statement
To finance phase III development of cobitolimod we have just completed a successful rights issue of approximately SEK 533 million. The subscription ratio amounted to as much as 153 percent and more than 99 percent was subscribed for by exercise of subscription rights. I would like to thank existing and new shareholders for the strong support in the rights issue, and extend a special welcome to HBM Healthcare Investments and Handelsbanken Funds as new large owners. These are two internationally recognized and successful life sciences specialists that have chosen to invest significant amounts, SEK 63.5 million and SEK 30 million respectively, which not only strengthens the ownership base, but also constitutes a strong validation of the potential of InDex.

The rights issue will primarily fund the important initial induction study in a sequential phase III program for left-sided moderate to severe ulcerative colitis. The results of this induction study will constitute a significant value inflection point and the remaining program can be optimised according to the outcome of the study.

We plan to start the study in the second quarter of 2021, subject to the Covid-19 pandemic, and we estimate that it will take 18 to 24 months to complete from initiation. Next step in our preparations is to finalize the agreement with the leading global contract research organisation that we have selected to conduct the study. The clinical study must then be approved by the authorities of each participating country.

It will be a global study with approximately 400 patients at a few hundred clinics. The primary endpoint, clinical remission, is to be measured at week 6. Apart from the dosing 250 mg x 2, which was the highest dose and the one that showed the best efficacy in the phase IIb study CONDUCT, cobitolimod’s excellent safety profile allows to also evaluate a higher dose, 500 mg x 2, in an adaptive study design. This higher dose has the potential to provide an even better efficacy than what was observed in the CONDUCT study.

For those who want to know more about the phase III design, cobitolimod and ulcerative colitis, I highly recommend the webcast from the virtual R&D day which can be found on our website. The ulcerative colitis patient Jonas Eriksson gave a first-hand account of the problem that many patients do not respond to or experience severe side effects from current treatments. Two key opinion leaders within inflammatory bowel disease and Apex Healthcare Consulting, who has conducted market research on cobitolimod, also participated, as well as InDex’s management.

InDex has a well-developed network of key opinion leaders and we established a North American advisory board in 2020. Recently, we have also formalized a European equivalent where several of the members have collaborated with InDex for a long time, and we have managed to attract a couple of new experts to the group as well.

Thanks to its outstanding combination of efficacy and safety, as well as the novel and unique mechanism of action, cobitolimod is positioned to be an essential part of the future treatment of ulcerative colitis and thereby improve the quality of life for patients suffering from the disease.

With the equity financing secured until the next pivotal read-out of clinical data, it feels very inspiring to now advance cobitolimod into phase III, which is the final stage of development before application for market approval.

On February 25, 2021 MannKind Corporation (NASDAQ:MNKD) reported financial results for the fourth quarter and full year ended December 31, 2020 (Press release, Mannkind, FEB 25, 2021, View Source [SID1234575627]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Our fourth quarter produced exceptional results, with $10.1 million in Afrezza net revenue and positive clinical data for Tyvaso DPI from the BREEZE study conducted by United Therapeutics," said Michael Castagna, Chief Executive Officer of MannKind Corporation. "UT also announced their plan to submit a new drug application for Tyvaso DPI to the FDA in April 2021. During the fourth quarter, we solidified our new direction with the acquisition of QrumPharma, which added a nebulized version of clofazimine to our pipeline of therapies for orphan lung diseases, and we entered into a collaboration agreement with Vertice for the co-promotion of Thyquidity, which is indicated for hyperthyroidism and is expected to expand our reach into endocrine diseases."

Fourth Quarter 2020 Results

Total revenues were $18.4 million for the fourth quarter of 2020, reflecting Afrezza net revenue of $10.1 million and collaborations and services revenue of $8.4 million. Afrezza net revenue increased 30% compared to $7.8 million in the fourth quarter of 2019, primarily driven by higher product demand with a more favorable mix of Afrezza cartridges and more favorable gross-to-net deductions. Collaborations and services revenue increased $0.2 million compared to the fourth quarter of 2019.

Afrezza gross profit for the fourth quarter of 2020 was $6.4 million compared to $3.1 million in the same period of 2019, an increase of $3.3 million, or 105%, that was driven by a combination of increased Afrezza revenue and a reduction in cost of goods sold.

In-process research and development expense for the fourth quarter of 2020 was $13.2 million, reflecting the acquisition of QrumPharma for approximately $12.8 million in total consideration and approximately $0.4 million in transaction costs. The acquisition of QrumPharma was accounted for as an asset acquisition and expensed on the date of acquisition as substantially all of the fair value of the assets acquired was concentrated in a single asset that consisted of in-process research and development in a pre-clinical development state.

Research and development expenses for the fourth quarter of 2020 were $1.5 million compared to $2.0 million for the fourth quarter of 2019. This decrease was mainly related to lower clinical trial spending.

Selling, general and administrative expenses for the fourth quarter of 2020 were $17.1 million compared to $15.7 million for the fourth quarter of 2019. This increase of $1.4 million, or 9%, was primarily attributable to a $1.2 million increase in personnel costs related to the expansion of our sales and medical field force.

During the fourth quarter of 2020, loss on foreign currency translation for insulin purchase commitments, which are denominated in Euros, was $4.0 million compared to $2.6 million for the fourth quarter of 2019. The fluctuation was due to a change in the U.S. dollar to Euro foreign exchange rate.

Interest expense on debt for the fourth quarter of 2020 was $2.4 million compared to $2.3 million for the fourth quarter of 2019.

The net loss for the fourth quarter of 2020 was $26.4 million, or $0.11 per share, compared to $14.3 million in the fourth quarter of 2019, or $0.07 per share. The increase in the net loss of $12.1 million was primarily due to the write-off of in-process research and development related to the acquisition of QrumPharma. On a non-GAAP basis, excluding the expense incurred for the acquisition of QrumPharma, the net loss for the fourth quarter of 2020 was $13.2 million, or $0.06 per share.

Twelve Months Ended December 31, 2020

Total revenues were $65.1 million for the year ended December 31, 2020, reflecting Afrezza net revenue of $32.3 million and collaborations and services revenue of $32.8 million. Afrezza net revenue increased 28% compared to $25.3 million for the year ended December 31, 2019, primarily driven by higher product demand with a more favorable mix of Afrezza cartridges, a price increase and more favorable gross-to-net deductions, all of which was partially offset by a reduction in sales to Biomm (Brazil). Collaborations and services revenue decreased $4.9 million compared to the full year ended December 31, 2019, primarily driven by a $5.8 million decrease in revenue recognized from the UT Research Agreement, which was substantially completed in the second quarter of 2019.

Afrezza gross profit was $17.2 million for the year ended December 31, 2020, an increase of $12.0 million, or 230%, compared to a gross profit of $5.2 million in the same period in 2019, primarily due higher commercial product sales combined with a reduction in cost of goods sold.

In-process research and development expense for the year ended December 31, 2020 was $13.2 million, reflecting the research and development acquired and expensed from the acquisition of QrumPharma for approximately $12.8 million in total consideration and approximately $0.4 million in transaction costs.

Research and development expenses for the year ended December 31, 2020 were $6.2 million compared to $6.9 million for the year ended December 31, 2019. This decrease of $0.7 million, or 9%, was primarily attributable to lower clinical trial spending.

Selling, general and administrative expenses for the year ended December 31, 2020 were $59.0 million compared to $74.7 million for the year ended December 31, 2019. This decrease of $15.6 million, or 21%, was primarily attributable a $9.3 million decrease in costs for television advertising for Afrezza, a $4.1 million decrease in promotional and marketing activities in response to the COVID-19 pandemic and a $2.5 million decrease in professional fees.

An impairment of $1.9 million was recognized for the year ended December 31, 2020 on a commitment asset and debt issuance costs related to future funding commitments of the MidCap Credit Facility. There were no asset impairments for the year ended December 31, 2019.

For the year ended December 31, 2020, foreign currency translation for insulin purchase commitments, which are denominated in Euros, resulted in a loss of $8.0 million compared to a gain of $1.9 million for the year ended December 31, 2019. The fluctuation was due to a change in the U.S. dollar to Euro foreign exchange rate.

Interest expense on debt for the year ended December 31, 2020 was $9.5 million compared to $10.9 million for the year ended December 31, 2019. This $1.4 million decrease was primarily attributable to a $3.4 million milestone obligation to Deerfield that was achieved in the third quarter of 2019 and a decrease of $0.8 million of interest expense related to the Deerfield Credit Facility, which was extinguished in the third quarter of 2019. This decrease was partially offset by an increase in interest expense from the MidCap Credit Facility of $2.3 million and an increase in interest expense from our Mann Group promissory notes of $0.6 million in 2020.

The net loss for the year ended December 31, 2020 was $57.2 million, or $0.26 per share, compared to $51.9 million net loss for the year ended December 31, 2019, or $0.27 per share. The higher net loss was mainly attributable to the write-off of in-process research and development related to the acquisition of QrumPharma and a loss on foreign currency translation related to insulin purchase commitments denominated in Euros, offset by a decrease in selling, general and administrative expenses. On a non-GAAP basis, excluding the expense incurred for the acquisition of QrumPharma, the net loss for the year ended December 31, 2020 was $44.0 million, or $0.20 per share.

Cash, cash equivalents, restricted cash, and short-term investments at December 31, 2020 was $67.2 million compared to $50.2 million at December 31, 2019.

Debt Reductions Subsequent to December 31, 2020

Pursuant to the terms of the senior convertible notes, the Company forced the conversion of all $5.0 million in principal of such notes into 1,666,667 shares of the Company’s common stock.

In addition, the Mann Group converted $9.6 million of principal and $0.4 million of accrued interest on its convertible promissory note into 4.0 million shares of the Company’s common stock. As of the date hereof, $53.4 million in principal remains outstanding under the promissory notes held by the Mann Group ($18.4 of which is convertible).

Sale-Leaseback of the Danbury Manufacturing Facility

Subsequent to December 31, 2020, the Company entered into a non-binding letter of intent ("LOI") with a third party to sell and lease back a portion of the Company’s Danbury manufacturing facility and administrative offices. The terms of the LOI include a sales price of approximately $95 million – $105 million, a lease term of 20 years with four 5-year renewal options, and annual rent of approximately $10 million – $11 million at the beginning of the lease. If the transaction is completed, the Company intends to use the proceeds for general corporate purposes, and may also pay down a portion of its senior secured debt. The completion of the transactions contemplated by the LOI is subject to certain conditions, including the negotiation of satisfactory definitive agreements and satisfactory results of the buyer’s inspections and other investigations, all of which are anticipated to be completed during the first quarter of 2021. However, there can be no assurances that this proposed transaction will be completed in the timeframe or on the principal terms set forth above, or at all.

Non-GAAP Measures

Certain financial information contained in this press release is presented on both a reported basis (GAAP) and a non-GAAP basis. Reported results were prepared in accordance with GAAP whereas non-GAAP measures exclude items described in the reconciliation tables below. Non-GAAP financial information is intended to portray the results of our baseline performance, supplement or enhance management, analysts and investors overall understanding of our underlying financial performance and facilitate comparisons among current and past periods. The non-GAAP financial measures are in addition to, not a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP.

Conference Call

MannKind will host a conference call and presentation webcast to discuss these results today at 9:00 a.m. Eastern Time. Those interested in listening to the conference call live via the Internet may do so by visiting the Company’s website at View Source under News & Events. A replay will be available on MannKind’s website for 14 days.

On February 25, 2021 Ziopharm Oncology, Inc. ("Ziopharm" or the "Company") (Nasdaq: ZIOP), reported its financial results for the fourth quarter and year ended December 31, 2020 and provided several additional corporate updates (Press release, Ziopharm, FEB 25, 2021, View Source [SID1234575643]). The Company will host a conference call and webcast today at 4:30 pm ET.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Leadership Transition and Planning

The Company reported that Heidi Hagen, formerly Lead Independent Director, has been appointed Interim Chief Executive Officer, replacing Dr. Laurence Cooper, MD., Ph.D. effective February 25, 2021. Ms. Hagen is remaining a member of the Board of Directors.

Dr. Cooper is also stepping down from his seat on the Board of Directors and is expected to continue with the Company in a scientific advisory capacity to support the Company’s R&D programs. A search for a permanent Chief Executive Officer is underway.

Dr. Cooper said, "With the fantastic news we announced today regarding the IND clearance of our Library TCR-T clinical studies, the Company is well positioned as a leader in immuno-oncology using engineered T-cells. I will work with the Board on transitioning to an advisory role to support the organization on the science side, while allowing the Company to identify a complementary business leader who can drive our path to commercialization."

Ms. Hagen added, "One cannot overstate Laurence’s contribution to Ziopharm. His life’s work has been to bring innovation and hope to patients suffering from the devastating impact of cancer. We will continue down the path Laurence has laid before us, and look forward to his continued involvement to help us address the scientific challenges ahead."

Ms. Hagen has served on the Board since June 2019. She is co-founder of Vineti, a cloud-based software platform company that addresses challenges in data management from order through cell collection, manufacturing, and delivery of personalized treatments such as cell and gene therapies and cancer vaccines. She has extensive experience in operations management and commercializing innovative technologies.

The Company also announced today that James Huang has been appointed Executive Chairman of the Board effective February 25, 2021.

Mr. Huang said, "On behalf of the entire Board we thank Laurence for his leadership and vision and express our full support for Heidi while we conduct a comprehensive search for a permanent CEO. We will strive to identify a leader with the business acumen to drive critical portfolio, development, commercial planning and capital allocation decision making that will help ensure the success of the Company."

Mr. Huang has served on the Board since July 2020 and has served as Chairman since January 2021. He is currently a Managing Partner at Kleiner Perkins Caufield & Byers (KPCB) China. He has founded and financed several innovative life sciences companies, including GenScript, Legend Biotech and Zai Lab. He is also Founding Partner of Panacea Venture, which formed TriArm Therapeutics, the funding partner for Ziopharm’s joint venture, Eden BioCell.

FDA IND Clearance for the Company’s Library TCR-T Clinical Phase I/II Trial

The Company reported it has received IND clearance by the U.S. Food and Drug Administration (FDA) for the Company’s TCR-T trial utilizing six "hotspot" TCRs from its library. The Company anticipates enrolling patients in the Phase I/II clinical trial across a variety of solid tumor cancers in the second half of the year.

The Company is working closely with MD Anderson to begin identifying patients for this trial. The trial will address a range of solid tumors, across gynecologic, colorectal, pancreatic, non-small cell lung and cholangiocarcinoma cancers.

"We are very excited to have received clearance for this IND and look forward to initiating the Library TCR-T trial, representing a tremendous amount of work by the team and the culmination of efforts by so many dedicated employees," said Dr. Eleanor de Groot, Ph.D., Executive Vice President and General Manager of Cell Therapy of Ziopharm. "We believe our cell therapy Sleeping Beauty platform technology has the potential to deliver non-viral engineered T-cell therapies to address significant unmet patient need and are excited by this important transition to clinical development for the Library program."

Additional Details Regarding R&D Day March 11, 2021

The Company provided additional details regarding the previously announced virtual R&D Day focusing on cell therapy on Thursday, March 11, 2021 at 11:00 am ET. Members of Ziopharm’s management team will provide an overview of the Company’s strategy, programs, and pipeline.

The session will also include presentations by leading key opinion leaders: Dr. Steven Rosenberg, Chief of Surgery at the National Cancer Institute; Dr. Carl June, Chair of the Ziopharm Scientific Advisory Board and Director of the Center for Cellular Immunotherapies and Director of Translational Research in the Abramson Cancer Center of the University of Pennsylvania; and Dr. Scott Kopetz, Colorectal Cancer Physician Scientist, NCI Colon Task Force Chair, Professor, and Deputy Chair at The University of Texas, MD Anderson Cancer Center.

"We are very excited to share updates on our suite of distinctive cell therapy programs and delighted to have top key opinion leaders joining us to provide their views and perspectives. We will be highlighting the unique attributes of Ziopharm and the encouraging progress in our programs," said Dr. Raffaele Baffa, M.D., Ph.D., Chief Medical Officer of Ziopharm.

Fourth Quarter 2020 Financial Results

Research and development expenses were $14.0 million for the fourth quarter of 2020, compared to $10.2 million for the fourth quarter of 2019, primarily reflecting increased clinical trial activity.

General and administrative expenses were $8.8 million for the fourth quarter of 2020, compared to $5.8 million for the fourth quarter of 2019. The increase in general and administrative expenses for the fourth quarter of 2020 is primarily due to increased legal costs, investor relations costs and facility charges.

Net loss for the fourth quarter of 2020, was $22.8 million, or $(0.11) per share, compared to a net loss of $15.7 million, or $(0.09) per share, for the fourth quarter of 2019.

Cash and cash equivalents, as of December 31, 2020 were $115.1 million. This cash position is sufficient to fund Company operations into the second quarter of 2022.

A prepayment of approximately $8.1 million remains for work to be conducted by the Company at MD Anderson under the Company’s research and development agreements.
Full Year 2020 Financial Results

Net loss applicable to the common shareholders for the year ended December 31, 2020 was $80.0 million, or $(0.38) per share, basic and diluted, compared to net loss applicable to the common shareholders of $117.8 million, or $(0.70) per share, basic and diluted, for the year ended December 31, 2019.

Research and development expenses were $52.7 million for the year ended December 31, 2020, compared to $38.3 million for the year ended December 31, 2019. The increase in research and development expenses for the year ended December 31, 2020 is primarily due to increased manufacturing, headcount, and clinical trial activity.

General and administrative expenses were $27.7 million for the year ended December 31, 2020, compared to $19.5 million for the year ended December 31, 2019. The increase in general and administrative expenses for the year ended December 31, 2020 is primarily due to increased legal costs, investor relations costs and facility charges.
Fourth Quarter and Full Year 2020 Results Conference Call and Webcast Details
Ziopharm will host a conference call and webcast for the investment community today, February 25, 2021, at 4:30 pm ET. The conference call can be accessed by dialing 877-451-6152 (U.S. and Canada) or +1-201-389-0879 (International). The passcode for the conference call is 13715482. To access the live webcast or the subsequent archived recording, click here or visit the "Investors" section of the Ziopharm website at www.ziopharm.com. The webcast will be recorded and available for replay on the company’s website for 90 days.

R&D Day Conference Call and Webcast Details – March 11, 2021, 11:00am ET
Interested participants can register for and view the webcast using this link or by visiting the "Investors" section of the Ziopharm website at www.ziopharm.com. The live Q&A session can be accessed by dialing 866-548-4713 (U.S. and Canada) or +1-323-794-2093 (International). The conference ID for the call is 5859801. The session will be recorded and available for replay on the Company’s website for 90 days.

On February 25, 2021 Acorda Therapeutics, Inc. (NASDAQ: ACOR) reported that it will host a conference call and webcast in conjunction with its fourth quarter and year end 2020 update and financial results on Thursday, March 4 at 4:30 p.m. ET (Press release, Acorda Therapeutics, FEB 25, 2021, View Source [SID1234575671]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

To participate in the Webcast/Conference Call, please note there is a new pre-registration process.

To register for the Webcast, use the link below:
View Source
To register for the Conference Call, use the link below:
View Source
**When registering please type your phone number with no special characters**
Once you have registered, you will receive a confirmation email with Webcast/Conference Call details. For the Webcast you will receive an email 2 hours prior to the start of the call with the link to join. The presentation will be available on the Investors section of www.acorda.com.

A replay of the call will be available from 7:30 p.m. ET on March 4, 2021 until 11:59 p.m. ET on April 3, 2021. To access the replay, please dial (800) 585-8367 (domestic) or (416) 621-4642 (international); reference code 9854802. The archived webcast will be available in the Investor Relations section of the Acorda website at www.acorda.com.

On February 25, 2021 Harvard University and Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE:4151) reported that they have entered into a strategic research alliance (Press release, Harvard University, FEB 25, 2021, View Source [SID1234575687]). The 5-year alliance, established by Harvard’s Office of Technology Development (OTD), aims to fuel scientific collaboration among academic and industry researchers to accelerate discovery and early-stage innovation in translational biomedical science.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Kyowa Kirin is a Japan-based global specialty pharmaceutical company with drug discovery and commercialization capabilities focused in core therapeutic areas of nephrology, oncology, immunology and allergy, and the central nervous system. By creating opportunities for formal scientific collaboration, the alliance will leverage industry insight and drug development expertise to advance biomedical innovations developed in Harvard labs toward the clinical development of important new therapies.

"Fundamental research conducted in Harvard’s life-science labs expands our basic understanding of the biological mechanisms of disease and identifies promising new approaches to treatment," said Vivian Berlin, Managing Director of Strategic Partnerships in Harvard OTD. "By building collaborative scientific relationships around the world, like this alliance with Kyowa Kirin, we are crafting an environment where industry leadership, resources, and new scientific perspectives may help to validate and develop those innovations toward life-changing treatments for the benefit of patients."

"I am very pleased that Kyowa Kirin will have the opportunity to work and collaborate with the faculty at one of the world’s leading institutions to advance drug discovery and biomedical science," said Yoshifumi Torii, Ph.D., Executive Officer, Vice President, Head of R&D Division of Kyowa Kirin. "One of our most important R&D strategies is to pursue external opportunities to generate scientific innovative value through strategic collaborations with industry and academia. I’m confident that this alliance will lead us toward novel and promising therapies for patients in the future."

Projects under the alliance will be initiated by Harvard’s leading life-science faculty through a proposal process. Projects selected for funding and scientific collaboration will be identified by a Joint Steering Committee, comprising membership from both Harvard and Kyowa Kirin.

Harvard OTD’s long-running alliance program creates multi-year, collaborative relationships between the University and corporate partners. These alliances support faculty-initiated research projects that can advance early-stage discoveries and rapidly drive innovation in a broad area of science. In establishing discussions with Kyowa Kirin that led to the creation of this research alliance, OTD was assisted by Gemseki, Inc., a subsidiary of Shin Nippon Biomedical Laboratories (SNBL), a preclinical CRO in Japan.