On January 23, 2019 Sierra Oncology, Inc. (Nasdaq: SRRA), a clinical stage drug development company focused on advancing targeted therapeutics for the treatment of patients with significant unmet needs in hematology and oncology, reported that its Chief Scientific Officer, Dr. Christian Hassig, will present "Addressing Intrinsic & Acquired PARP Inhibitor (PARPi) Resistance Through Chk1 Inhibition" at the DNA Damage Response (DDR) Therapeutics Summit in Boston, MA (Press release, Sierra Oncology, JAN 23, 2019, View Source [SID1234532829]). The presentation is scheduled for 9:00 am Eastern Time (ET) on January 30, 2019.

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"Targeting components of the DDR machinery that regulate replication stress, such as Chk1, represents an attractive therapeutic strategy to address both intrinsic and acquired PARPi resistance," noted Dr. Hassig. "For example, CCNE1-driven tumors, frequently found in high grade serous ovarian, breast and endometrial cancers, are associated with high replication stress and are generally insensitive to PARPi therapy. We have demonstrated that our Chk1 inhibitor, SRA737, plus low dose gemcitabine is highly effective in CCNE1-amplified preclinical models, where low-dose gemcitabine induces an additional exogenous form of replication stress further enhancing sensitivity to Chk1 inhibition. Moreover, PARPi acquired resistance is driven, in part, through increased replication fork stabilization and partial recovery of homologous recombination repair, two processes regulated by Chk1. As such, our preclinical results suggest that combining PARPi with SRA737 may prove effective in treating this significant emerging clinical issue."

Sierra Oncology is a key sponsor of the DNA Damage Response Therapeutics Summit, which will gather leading stakeholders from across drug development over two days to discuss how to advance the therapeutic potential of targeting DNA repair pathways.

Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

Sierra also announced that on January 21, 2019 the Compensation Committee of Sierra Oncology’s Board of Directors granted non-qualified stock options to purchase an aggregate of 141,000 shares of its common stock to 5 new employees under Sierra Oncology’s 2018 Equity Inducement Plan.

The 2018 Equity Inducement Plan is used exclusively for the grant of equity awards to individuals who were not previously an employee or non-employee director of Sierra (or following a bona fide period of non-employment), as an inducement material to such individual’s entering into employment with Sierra, pursuant to Rule 5635(c)(4) of the Nasdaq Listing Rules.

The options have an exercise price of $1.41 per share, which is equal to the closing price of Sierra’s common stock on January 22, 2018, the first day on which markets are open following the date of grant. Each option will vest and become exercisable as to 25% of the shares on the first anniversary of the recipient’s start date, and then will vest and become exercisable as to the remaining 75% of the shares in 36 equal monthly installments following the first anniversary, in each case, subject to each such employee’s continued employment with Sierra on such vesting dates. The options are subject to the terms and conditions of Sierra’s 2018 Equity Inducement Plan, and the terms and conditions of the stock option agreement covering the grant.

On January 23, 2019 Abbott reported financial results for the fourth quarter and full year ended Dec. 31, 2018, and issued financial outlook for 2019 (Press release, Abbott, JAN 23, 2019, View Source [SID1234532828]) (Press release, Abbott, JAN 23, 2019, View Source [SID1234532828]).

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· Full-year 2018 worldwide sales of $30.6 billion increased 11.6 percent on a reported basis and 7.3 percent on an organic* basis.

· Reported diluted EPS from continuing operations under GAAP was $1.31 in the full year 2018 and adjusted diluted EPS from continuing operations, which excludes specified items, was $2.88, reflecting 15.2 percent growth1.

· Fourth-quarter worldwide sales of $7.8 billion increased 2.3 percent on a reported basis and 6.4 percent on an organic basis.

·Reported diluted EPS from continuing operations under GAAP was $0.37 in the fourth quarter and adjusted diluted EPS from continuing operations, which excludes specified items, was $0.81.

·Abbott issues full-year 2019 guidance for organic sales growth of 6.5 to 7.5 percent2, which excludes the impact of foreign exchange, and diluted EPS from continuing operations on a GAAP basis of $1.80 to $1.90. Projected full-year adjusted diluted EPS from continuing operations is $3.15 to $3.25, reflecting double-digit growth at the mid-point.

· In 2018, Abbott generated strong operating cash flow and paid down more than $8 billion of debt.

·During 2018, Abbott returned $2 billion to shareholders in the form of dividends and, in December, announced a 14.3 percent increase in its quarterly common dividend.

·In October, Abbott received U.S. FDA approval of its HeartMate 3TM left ventricular assist device as a destination (long-term use) therapy. In January 2019, Abbott announced U.S. FDA approval of its TactiCathTM Contact Force Ablation Catheter, Sensor EnabledTM, a new catheter designed to help physicians accurately and effectively treat atrial fibrillation, a form of irregular heartbeat.

"2018 was another outstanding year for Abbott," said Miles D. White, chairman and chief executive officer, Abbott. "We exceeded the organic sales growth range we set at the beginning of the year, achieved a number of significant advances in our pipeline, and significantly improved our balance sheet and strategic flexibility. We’re very well-positioned heading into 2019."

FOURTH-QUARTER AND FULL-YEAR 2018 BUSINESS OVERVIEW

Note: Management believes that measuring sales growth rates on an organic basis is an appropriate way for investors to best understand the underlying performance of the business.

For 2018, Organic sales growth:

· Excludes prior year results for the Abbott Medical Optics (AMO) and St. Jude Medical vascular closure businesses, which were divested during the first quarter 2017;

· Excludes the current and prior year results for Rapid Diagnostics, which reflect results for Alere Inc., which was acquired on Oct. 3, 2017;

· Excludes the prior year fourth quarter results for a non-core business within U.S. Adult Nutrition, which was discontinued during the third quarter 2018; and

· Excludes the impact of foreign exchange.

Total YTD 2018 Abbott sales from continuing operations include Other Sales of $62 million.

Note: In order to compute results excluding the impact of exchange rates, current year U.S. dollar sales are multiplied or divided, as appropriate, by the current year average foreign exchange rates and then those amounts are multiplied or divided, as appropriate, by the prior year average foreign exchange rates.

Fourth-quarter 2018 worldwide sales of $7.8 billion increased 2.3 percent on a reported basis. On an organic basis, worldwide sales increased 6.4 percent. For the full-year 2018, worldwide sales increased 11.6 percent on a reported basis and 7.3 percent on an organic basis. Refer to pages 16 and 17 for a reconciliation of adjusted historical revenue.

Worldwide Nutrition sales decreased 0.4 percent on a reported basis in the fourth quarter. On an organic basis, sales increased 3.6 percent. For the full-year 2018, worldwide sales increased 4.4 percent on a reported basis and 5.2 percent on an organic basis. Refer to pages 16 and 17 for a reconciliation of adjusted historical revenue.

Worldwide Pediatric Nutrition sales increased 1.2 percent on a reported basis in the fourth quarter, including an unfavorable 2.5 percent effect of foreign exchange, and increased 3.7 percent on an organic basis. International pediatric sales decreased 0.8 percent on a reported basis, including an unfavorable 4.5 percent effect of foreign exchange, and increased 3.7 percent on an organic basis. Performance in the quarter was led by above-market growth in the U.S. and strong growth across several markets in Asia and Latin America, including China, Vietnam and Mexico.

Worldwide Adult Nutrition sales decreased 2.5 percent on a reported basis in the fourth quarter, and increased 3.5 percent on an organic basis. International adult sales increased 0.9 percent on a reported basis, including an unfavorable 5.7 percent effect of foreign exchange, and increased 6.6 percent on an organic basis. Worldwide sales performance was led by strong growth of Ensure, Abbott’s market-leading complete and balanced nutrition brand, and Glucerna, Abbott’s market-leading diabetes-specific nutrition brand.

Rapid Diagnostics reflects sales from Alere Inc., which was acquired on Oct. 3, 2017. Organic growth rates above exclude results from the Rapid Diagnostics business.

n/a = Percent change is not applicable as organic results exclude Rapid Diagnostics in 2018.

Rapid Diagnostics reflects sales from Alere Inc., which was acquired on Oct. 3, 2017. Organic growth rates above exclude results from the Rapid Diagnostics business.

n/m = Percent change is not meaningful.

Worldwide Diagnostics sales increased 2.9 percent on a reported basis in the fourth quarter. On an organic basis, sales increased 7.4 percent. For the full-year 2018, worldwide sales increased 33.5 percent on a reported basis and 6.7 percent on an organic basis. Refer to pages 16 and 17 for a reconciliation of adjusted historical revenue.

Core Laboratory Diagnostics sales increased 5.0 percent on a reported basis in the fourth quarter, including an unfavorable 4.4 percent effect of foreign exchange, and increased 9.4 percent on an organic basis, reflecting above-market growth in the U.S. and internationally, where Abbott is seeing continued strong adoption of Alinity TM, Abbott’s family of innovative and highly differentiated diagnostic instruments.

Molecular Diagnostics sales increased 1.4 percent on a reported basis in the fourth quarter, including an unfavorable 2.4 percent effect of foreign exchange, and increased 3.8 percent on an organic basis. Worldwide sales were led by growth in infectious disease testing, Abbott’s core area of focus in the molecular diagnostics market.

Point of Care Diagnostics sales decreased 5.5 percent on a reported basis in the fourth quarter, including an unfavorable 0.4 percent effect of foreign exchange, and decreased 5.1 percent on an organic basis.

Rapid Diagnostics worldwide sales of $548 million were led by infectious disease and cardiometabolic testing.

Established Pharmaceuticals sales decreased 4.8 percent on a reported basis in the fourth quarter, including an unfavorable 8.4 percent effect of foreign exchange, and increased 3.6 percent on an organic basis. As expected, sales growth in the fourth quarter was negatively impacted by a comparison versus the fourth-quarter of 2017, when organic sales grew 14.0 percent.

Key Emerging Markets include India, Brazil, Russia and China along with several additional emerging countries that represent the most attractive long-term growth opportunities for Abbott’s branded generics product portfolio. Sales in these geographies decreased 6.2 percent on a reported basis in the fourth quarter, including an unfavorable 10.5 percent effect of foreign exchange, and increased 4.3 percent on an organic basis. For the full-year 2018, sales in key emerging markets increased 1.7 percent on a reported basis and 7.4 percent on an organic basis led by double-digit growth in India and China.

Other sales increased 0.2 percent on a reported basis in the fourth quarter and 1.3 percent on an organic basis. For the full-year 2018, Other sales increased 8.1 percent on a reported basis and 5.8 percent on an organic basis.

Worldwide Medical Devices sales increased 6.7 percent on a reported basis in the fourth quarter. On an organic basis, sales increased 9.0 percent. For the full-year 2018, worldwide sales increased 10.1 percent on a reported basis and 9.1 percent on an organic basis. Refer to page 17 for a reconciliation of adjusted historical revenue.

In Electrophysiology, growth was led by strong performance in cardiac mapping and ablation catheters. In January 2019, Abbott announced U.S. FDA approval of its TactiCath Contact Force Ablation Catheter, Sensor Enabled, a new catheter designed to help physicians accurately and effectively treat atrial fibrillation.

Growth in Structural Heart was driven by several product areas across Abbott’s broad portfolio, including AMPLATZERTM PFO Occluder, a device designed to close a hole-like opening in the heart, and MitraClip, Abbott’s market-leading device for the minimally invasive treatment of mitral regurgitation, a leaky heart valve.

In Diabetes Care, sales increased 28.3 percent on a reported basis and 32.4 percent on an organic basis in the fourth quarter, led by rapid market uptake of FreeStyle Libre, Abbott’s revolutionary sensor-based continuous glucose monitoring system, which removes the need for routine fingersticks3 for people with diabetes.

ABBOTT ISSUES GUIDANCE FOR 2019

Abbott is issuing full-year 2019 guidance for organic sales growth of 6.5 to 7.5 percent2, which excludes the impact of foreign exchange, and diluted earnings per share from continuing operations under Generally Accepted Accounting Principles (GAAP) of $1.80 to $1.90. Abbott forecasts net specified items for the full year 2019 of $1.35 per share. Specified items include intangible amortization expense, acquisition-related expenses, charges associated with cost reduction initiatives and other expenses. Excluding specified items, projected adjusted diluted earnings per share from continuing operations would be $3.15 to $3.25 for the full year 2019.

Abbott is issuing first-quarter 2019 guidance for diluted earnings per share from continuing operations under GAAP of $0.25 to $0.27. Abbott forecasts specified items for the first quarter 2019 of $0.35 per share primarily related to intangible amortization, acquisition-related expenses, cost reduction initiatives and other expenses. Excluding specified items, projected adjusted diluted earnings per share from continuing operations would be $0.60 to $0.62 for the first quarter.

ABBOTT ANNOUNCES INCREASE IN QUARTERLY DIVIDEND

Dec. 14, 2018, the board of directors of Abbott increased the company’s quarterly dividend to $0.32 per share from $0.28 per share, an increase of 14.3 percent. Abbott’s cash dividend is payable Feb. 15, 2019, to shareholders of record at the close of business on Jan. 15, 2019. This marks the 380th consecutive quarterly dividend to be paid by Abbott.

Abbott has increased its dividend payout for 47 consecutive years and is a member of the S&P 500 Dividend Aristocrats Index, which tracks companies that have annually increased their dividend for at least 25 consecutive years.

On January 23, 2019 ProMIS Neurosciences Inc. ("ProMIS" or the "Company") (TSX: PMN); (OTCQB:ARFXF) is reported that it has closed a private placement of 9,560,000 units (the "Units") at a price of CDN$0.23 (or US$0.173) per Unit (the "Offering Price") for gross proceeds of approximately CDN$2,198,800 (the "Offering") (Press release, ProMIS Neurosciences, JAN 23, 2019, View Source [SID1234532827]).

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"We are pleased with the completion of this private placement", stated Dr. Elliot Goldstein, ProMIS President and CEO. "The additional funds allow us to capitalize on the continued interest we are seeing from large pharma in our programs targeting toxic forms of alpha-synuclein for Parkinson’s disease (PD) and TDP43 for ALS (amyotrophic lateral sclerosis). ProMIS will continue to generate data showing the high degree of selectivity and competitive advantages of ProMIS novel antibody programs with a view to accelerate a possible partnering deal for our PD and ALS assets."

Each Unit consisted of one common share of the Company (each a "Share") and one share purchase warrant of the Company (each a "Warrant"). Each Warrant will entitle the holder thereof to purchase one Share ("a "Warrant Share") at an exercise price of $0.48 per Warrant Share at any time for five years following the closing date of the Offering (the "Closing Date"). The expiry date of the Warrants is subject to acceleration such that if following the four month anniversary of the Closing Date, the twenty-day volume-weighted average trading price ("20 day VWAP") of the Shares on the TSX is greater than $1.00, or the Company enters into a partnering deal within 18 months of the closing of the Offering with minimum proceeds of US$5 million and the 20 day VWAP is greater than $0.48 at any time following the announcement of such a partnering deal. The Company may accelerate the expiry date of the Warrants by issuing a press release announcing the reduced warrant term whereupon the Warrants will expire on a day that is not less than 30 calendar day after the date of such press release.

In connection with the Offering, the Company paid to qualified finders a cash commission in the aggregate amount of $39,445 (the "Finder’s Fee") equal to 7% of the gross proceeds from the sale of Units to purchasers introduced by such finders. The Company also issued a total of 164,500 finder’s warrants (the "Finder’s Warrants") equal to 7% of the number of Units sold to purchasers introduced by such finders. The Finder’s Warrants will have the same terms as the Warrants that form part of the Offering.

All securities issued in connection with the Offering will be subject to a statutory hold period expiring on May 23, 2019 in accordance with applicable securities laws. Net proceeds from the Offering are intended to be used for working capital and general corporate purposes.

Closing of the Offering is subject to customary conditions, including TSX final approval. The Offering was offered to qualified investors in the provinces of Alberta, British Columbia and Ontario, and otherwise in those jurisdictions where the Offering can lawfully be made including the United States under applicable private placement exemptions.

Three insiders of the Company subscribed for an aggregate of 556,214 units, which constitutes a "related party transaction" within the meaning of Multilateral Instrument 61-101 – Protection of Minority Security Holders in Special Transactions ("MI 61-101"). The issuances to the insiders are exempt from the formal valuation and the minority shareholder approval requirements of MI 61-101 as the fair market value of the units issued to or the consideration paid by such person did not exceed 25% of the Company’s market capitalization.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful. The securities issued, or to be issued, under the Offering have not been, and will not be, registered under the United States Securities Act of 1933, as amended, and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements

On January 22, 2019 Klaria AB (Klaria) (Parent Company, Klaria Pharma Holding AB, Stockholm OMX Nasdaq:KLAR) and Purdue Pharma (Canada) reported they have entered into an exclusive development agreement for KL-01401 (Epinephrine Oromucosal Film) (Press release, Purdue Pharma, JAN 22, 2019, View Source;license-and-supply-agreements-with-purdue-pharma–canada–for-th,c2724247 [SID1234553985]). KL-01401 is a developmental stage formulation of epinephrine for emergency treatment of severe anaphylactic reactions in patients who are at increased risk for anaphylaxis. KL-01401 will be co-developed by Klaria and Purdue Pharma (Canada). The development agreement includes exclusive global license and supply options for the independently associated Purdue/Napp/Mundipharma network of companies upon achievement of defined milestones.

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Under the terms of the agreement, the total value of all milestones achievable is 55.2 million US Dollars. In addition, Klaria will receive mid-to-upper single digit royalties on net sales. Further terms of the agreements give Klaria exclusive manufacturing rights to supply the global market with KL-01401.

In order to complete the agreement with Purdue, Klaria AB has also added epinephrine to its license agreement with Uppsalagruppen Medical AB. In the agreement between Klaria and Uppsalagruppen, Uppsalagruppen will receive a four precent royalty on Klaria’s net income from sales of KL-01401.

KL-01401 is based on Klaria’s novel patented drug delivery platform, which provides several benefits to patients who may require emergency treatment, for anaphylactic reactions. It is planned as an easy to use, non-injectable self-administered treatment that allows patients and their caregivers to discreetly carry a life-saving emergency treatment medication with them at all times.

Dr. Scott Boyer, CEO, Klaria commented: "We are extremely pleased and encouraged to enter into this agreement with Purdue – our second collaboration to date. This agreement combines the strengths of our patented drug delivery platform with a partner who is a leader in development and commercialization of innovative treatments. We are confident that the result of our partnership will meet an unmet medical need for patients relying on epinephrine in the event of a severe allergic reaction."

David Pidduck, President and CEO of Purdue Pharma (Canada) commented:"Today’s agreement signals an exciting move for Purdue as we endeavour to shift the treatment paradigm for Canadians living with the threat of an anaphylactic reaction. Anaphylaxis is the most serious type of allergic reaction and current treatment options continue to face increasing challenges, including availability. The deepening of our partnership with Klaria by entering into a second development agreement with them is another example of our commitment to investing in new technologies and treatment options that will make a positive impact on the healthcare system and on patients’ lives. This agreement is consistent with our overall strategy of expanding opportunities through business development."

On January 22, 2019 Notable Labs, a startup that accelerates drug development by matching drugs with patients who are most likely to respond, reported that it has launched its first drug development program, ND-1000, which targets pediatric and adult blood cancers (Press release, Notable Labs, JAN 22, 2019, View Source [SID1234532886]). In an industry first, the company has opted to donate the commercial rights to price, manufacture, and distribute ND-1000 for pediatric leukemia to global repurposing non-profit Cures Within Reach in order to provide the drug to pediatric leukemia patients at a very low cost.

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The partnership between Notable and Cures Within Reach is intended to further Cures Within Reach’s mission to develop and implement effective economic incentives for the repurposing of inexpensive generic drugs, devices, and other products which is especially critical in rare diseases. This collaborative venture will be supported by philanthropy from individuals, foundations and disease non-profits, as well as investment from for-profit stakeholders.

As a for-profit company, Notable Labs is able to donate ND-1000’s pediatric commercial rights to Cures Within Reach due to the drug’s eligibility for the FDA’s Pediatric Priority Review Voucher Program, which has a financial value due to an awarded voucher’s ability to be sold to another pharmaceutical company.

"We need to create and use incentives to secure approval for existing drugs that have additional therapeutic value," said Dr. Bruce Bloom, CEO, Cures Within Reach. "To our knowledge, this would be a unique therapeutic development partnership that creates both commercial value for shareholders and philanthropic impact at a significantly lower development cost. Our hope is that this type of alliance between a for-profit company and a non-profit organization to repurpose drugs and improve outcomes at lower costs to patients could become a model for others to use."

Notable Labs will open the first clinical trial for ND-1000 at The University of Kansas Cancer Center later this year through a partnership with the University’s Institute for Advancing Medical Innovation (IAMI). "We are thrilled to bring our drug repurposing and blood cancer clinical trial expertise to the unique partnership established by Notable Labs and Cures Within Reach," said IAMI Director Scott Weir, Pharm.D., Ph.D. "We are focused on bringing life-saving cancer treatments to patients and we are eager to enroll trial participants into the first clinical trial for ND-1000, joining this groundbreaking effort."

How Notable Labs works

Notable Labs has built an automated laboratory that rapidly evaluates thousands of drug combinations on cancer cells relative to healthy cells. A report is generated which prioritizes the drugs that are most specifically active against cancer cells. The first validation trials have been in blood cancers due to the accessibility and large number of cancer cells available.

The company was founded by Matt De Silva, whose father was diagnosed with Glioblastoma Multiforme, a deadly stage 4 brain cancer that claimed the lives of Beau Biden, John McCain, and Ted Kennedy. A hedge fund manager by background, Matt spent more than a year researching potential treatments and clinical trials, and realized that the physicians running the trials didn’t have the ability to accurately predict which medications would be most effective for his father. Unfortunately, cancer doesn’t wait, and Matt lost his father before he could find the right treatment. During that time Matt founded Notable Labs and built a platform that could solve the problem for other patients that he couldn’t for his own father.

"Our goal is to ensure that if a patient chooses to enroll on a clinical trial, they’ll have a strong chance of responding. If we can quickly and accurately match the right drugs with the right patients, the cost of clinical trials will drastically fall, enabling reduced drug prices that our healthcare system desperately needs," said De Silva, CEO and Founder of Notable Labs. "The work we do in our lab and this partnership with Cures Within Reach and the KU Cancer Center will ensure that more families and patients will have access to this therapy in the future."

About Cures Within Reach
Cures Within Reach (CWR) is a US-based global philanthropic leader that improves patient quality and length of life by leveraging the speed, safety and cost-effectiveness of medical repurposing research, driving more treatments to more patients more quickly. CWR catalyzes research to facilitate and validate repurposing opportunities that create clinical impact, and enables and facilitates conversation and action among stakeholders that help transform healthcare through repurposing opportunities. Through repurposing, CWR drives both market impact and health savings to patients and patient groups, from academia/researchers, with payers and the healthcare industry and with support from the government, philanthropy and others. CWR’s repurposing research projects have generated "new" treatments in over a dozen indications, making patient impact through off-label use in clinical practice or through a commercialization track.

CWR currently has a global portfolio of more than 20 repurposing research projects, as well as more than 180 repurposing research projects available for funding in a wide range of diseases on its CureAccelerator site. Visit cureswithinreach.org or follow CWR via Twitter @CuresWReach, LinkedIn (LinkedIn.com/company/cures-within-reach), YouTube (YouTube.com/cureswithinreach) or Facebook (Facebook.com/CuresWithinReach).