ANI Pharmaceuticals Completes Acquisition of Generic Products and Assets from Amneal/Impax

• Immediate revenue and profit from twelve SKUs of three currently commercialized products: Ezetimibe-Simvastatin tablets, Felbamate tablets and Desipramine tablets. Starting today ANI will commence shipping to customers.
• Approved ANDAs for Aspirin/Dipyridamole ER capsules and Methylphenidate ER tablets; these products require successful validation prior to launch. ANI will immediately begin validation efforts for these two products.
• An option with a date certain launch for Aspirin/Dipyridamole ER capsules of no later than October 1, 2019. The option allows ANI to source the product from Amneal through March 1, 2021 or until ANI launches its own product, whichever date is earlier. If ANI elects to exercise the option to launch product supplied by Amneal it will owe a milestone payment of between $0 and $10 million depending on the number of generic products in the market at the time of launch. Currently this is a $120 million annual U.S. market with only one generic competitor, according to Iqvia/IMS Health.
• Two pipeline products: Erythromycin IR tablets and Diclofenac-Misoprostol DR tablets. ANI acquired a development package for Erythromycin IR tablets and will assume the development work for this product with the goal of filing an ANDA in the near future. Currently there is only one generic competitor for Erythromycin IR tablets. In addition, ANI has assumed a multi-year license, supply and distribution agreement for Diclofenac-Misoprostol DR tablets.

Arthur S. Przybyl, ANI’s President and CEO stated, “We are excited to add these products and the revenue and profit generated by today’s three product launches to our generic platform.  Importantly, we look forward to launching Aspirin/Dipyridamole ER capsules no later than October 1, 2019.  At the same time, we will begin validation efforts for Methylphenidate ER tablets, which represents a compelling opportunity for ANI.”

About ANI

ANI Pharmaceuticals, Inc. (the “Company” or “ANI”) is an integrated specialty pharmaceutical company developing, manufacturing, and marketing branded and generic prescription pharmaceuticals. The Company’s targeted areas of product development currently include narcotics, oncolytics (anti-cancers), hormones and steroids, and complex formulations involving extended release and combination products. For more information, please visit our website https://ift.tt/1qzAPQj.

Forward-Looking Statements 

To the extent any statements made in this release deal with information that is not historical, these are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about price increases, the Company’s future operations, products financial position, operating results and prospects , the Company’s pipeline or potential markets therefor, and other statements that are not historical in nature, particularly those that utilize terminology such as “anticipates,” “will,” “expects,” “plans,” “potential,” “future,” “believes,” “intends,” “continue,” other words of similar meaning, derivations of such words and the use of future dates. 

Uncertainties and risks may cause the Company’s actual results to be materially different than those expressed in or implied by such forward-looking statements. Uncertainties and risks include, but are not limited to, the risk that the Company may face with respect to importing raw materials; increased competition; acquisitions; contract manufacturing arrangements; delays or failure in obtaining product approval from the U.S. Food and Drug Administration; general business and economic conditions; market trends; products development; regulatory and other approvals and marketing.

More detailed information on these and additional factors that could affect the Company’s actual results are described in the Company’s filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and quarterly reports on Form 10-Q, as well as its proxy statement. All forward-looking statements in this news release speak only as of the date of this news release and are based on the Company’s current beliefs, assumptions, and expectations. The Company undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

For more information about ANI, please contact:
Investor Relations
IR@anipharmaceuticals.com

 

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LipimetiX Development Announces Sub-License of Apo E Mimetic Peptide Platform to Anji Pharma, China Other OTC:CAPS

NATICK, Mass., May 07, 2018 (GLOBE NEWSWIRE) — LipimetiX Development, Inc. (“LipimetiX” or “the Company”) announced today that Anji Pharmaceuticals, Inc. (“Anji Pharma”) has entered a licensing agreement for the LipimetiX platform of peptides (AEM-28 and analogs) for development of these drug candidates in commercial indications in mainland China, Taiwan and Hong Kong.  Anji Pharma’s mission is to license and develop promising therapeutic technologies that address under-served markets in China.

The Anji Pharma’s license provides exclusive rights to and use of the LipimetiX patent portfolio of Apo E mimetic peptides and formulations in the above-mentioned territory.  Terms include an upfront licensing payment to LipimetiX of US$2.0 million, multiple additional cash payments upon achievement of clinical/regulatory milestones and a royalty on Anji Pharma’s future pharmaceutical revenues derived from this program.  Further, the agreement provides for information sharing and other terms standard to a licensing agreement of this nature. 

Dennis Goldberg, Ph.D., CEO of LipimetiX, stated, “We welcome the Anji Pharma relationship to develop our lipid-lowering peptides in China.  The business opportunity was brought to us by a member of the LipimetiX Science Advisory Board, who has closely observed and contributed to our program’s success.  We are pleased by this validation of our science in Apo E mimetic peptides.”

Yiwei Zong, Ph.D., CEO of Anji Pharma, added, “We are excited to collaborate with LipimetiX in a program to address a large China and global clinical need.  The LipimetiX team has already shown proof-of-concept in lipid reduction in humans with AEM-28.  We look forward to helping progress these potent peptides through the next clinical development phases and, ultimately, to the market.”

Chimeric Apolipoprotein E Mimetic Peptides

Apolipoprotein E (Apo E) is in a class of protein that occurs throughout the body.  Apo E is essential for the normal metabolism of cholesterol and triglycerides.  After a meal, the postprandial (or post-meal) lipid load is packaged in lipoproteins and secreted into the blood stream.  Apo E targets cholesterol and triglyceride rich lipoproteins to specific receptors in the liver, decreasing the levels in the blood. Elevated plasma cholesterol and triglycerides are independent risk factors for atherosclerosis, the buildup of cholesterol rich lesions and plaques in the arteries.  Atherosclerosis is the major cause of cardiovascular disease, peripheral artery disease and cerebral artery disease, and can cause heart attack, loss of limbs and stroke.   Defective lipid metabolism also plays an important role in the development of adult onset diabetes mellitus (Type 2 diabetes), and diabetics are particularly vulnerable to atherosclerosis, heart and peripheral artery diseases.

The University of Alabama at Birmingham (“UAB”) scientists patented the first chimeric Apo E mimetic peptide in 1999, reducing the 299 amino acid native Apo E into a 28 amino acid, dual domain peptide that can be delivered therapeutically.  One domain inserts into a lipoprotein surface and the second domain binds to the Apo E receptors in the liver.  In 2010, the Company’s founding scientist, Dr. Dennis Goldberg, obtained worldwide right to patents for Apo E mimetic peptides from the UAB Research Foundation (“UABRF”).  The Company has an Exclusive License Agreement with the University of Alabama at Birmingham Research Foundation for AEM-28 and its analogs.

The Company has continued research into a next generation of chimeric Apo E peptides and has discovered new AEM-28 analogs, resulting in worldwide patent filings in 2015.  The AEM-28 analogs were found to be significantly more potent (as tested in multiple animal models) than the parent molecule.  Currently, the Company intends to concentrate its development efforts on AEM-28 analogs, including AEM-28-08 and AEM-28-14.  Commercial indication targets include Homozygous Familial Hypercholesterolemia and Acute Coronary Syndrome.

About Anji

Anji Pharma is a clinical stage pharmaceutical company dedicated to addressing China’s unmet clinical needs by identifying and in-licensing world-class clinical compounds and accelerating their clinical development in China.

About LipimetiX

LipimetiX Development, Inc. is a clinical stage biotechnology company committed to developing Chimeric Apo E Mimetic Peptides for multiple lipid reduction indications.  LipimetiX is approximately 60%-owned by Capstone Therapeutics Corp. (OTCQB:CAPS).

Capstone’s corporate headquarters are in Tempe, Arizona.  For more information, please visit Capstone’s website:  www.capstonethx.com.  For more information on LipimetiX Development, please visit the Company’s website:  www.lipimetix.com.

Statements in this press release or otherwise attributable to Capstone regarding our business that are not historical facts are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.  These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from predicted results.  These risks include the factors discussed in our Form 10-K for the fiscal year ended December 31, 2017, and other documents that Capstone files with the U.S. Securities and Exchange Commission.

Editor’s Note:  This press release is also available under the Investors section of Capstone’s website at www.capstonethx.com.

LipimetiX Development, Inc.
5 Commonwealth Road – Suite 2A
Natick, MA 01760
(508)651-3715
www.lipimetix.com 

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Oramed to Present at Conferences in May

NEW YORK, May 7, 2018 /PRNewswire/ — Oramed Pharmaceuticals Inc. (NASDAQ: ORMP) (TASE: ORMP) (www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, announced today that it will present at three conferences over the next two weeks.

DG Disruptive Growth and Healthcare Conference, panel discussion and corporate presentation

Date:                    May 8, 2018

Time:                    9:30 a.m. EDT (“Disruptive Science Panel”)

                             11:35 a.m. EDT (“Company Presentation”)

Location:               599 Lexington Avenue, 22nd floor, New York, NY

Presenter:             Nadav Kidron, CEO

Oppenheimer’s 19th Annual Israeli Conference, panel discussion

Date:                      May 13, 2018

Time:                     10:25 a.m. Israel time

Location:                The David InterContinental Hotel, Tel Aviv, Hall 1

Presenter:              Joshua Hexter, COO

17^th MIXiii-BIOMED 2018 Conference and Exhibition, corporate presentation

Date:                      May 15, 2018

Time:                      4:20 p.m. Israel time

Location:                The David InterContinental Hotel, Tel Aviv, Hall C

Presenter:               Nadav Kidron, CEO

About Oramed Pharmaceuticals

Oramed Pharmaceuticals is a technology pioneer in the field of oral delivery solutions for drugs currently delivered via injection. Established in 2006, Oramed’s Protein Oral Delivery (POD^TM) technology is based on over 30 years of research by top scientists at Jerusalem’s Hadassah Medical Center. Oramed is seeking to revolutionize the treatment of diabetes through its proprietary flagship product, an orally ingestible insulin capsule (ORMD-0801). The Company completed multiple Phase II clinical trials under an Investigational New Drug application with the U.S. Food and Drug Administration. In addition, Oramed is developing an oral GLP-1 analog capsule (ORMD-0901).

For more information, the content of which is not part of this press release, please visit www.oramed.com.

Forward-looking statements: This press release contains forward-looking statements. For example, we are using forward-looking statements when we discuss the timing of expected clinical development programs and clinical trials and FDA submissions or revolutionizing the treatment of diabetes with our products. These forward-looking statements are based on the current expectations of the management of Oramed only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements, including the risks and uncertainties related to the progress, timing, cost, and results of clinical trials and product development programs; difficulties or delays in obtaining regulatory approval or patent protection for our product candidates; competition from other pharmaceutical or biotechnology companies; and our ability to obtain additional funding required to conduct our research, development and commercialization activities. In addition, the following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; delays or obstacles in launching our clinical trials; changes in legislation; inability to timely develop and introduce new technologies, products and applications; lack of validation of our technology as we progress further and lack of acceptance of our methods by the scientific community; inability to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties that may develop with our process; greater cost of final product than anticipated; loss of market share and pressure on pricing resulting from competition; laboratory results that do not translate to equally good results in real settings; our patents may not be sufficient; and final that products may harm recipients, all of which could cause the actual results or performance of Oramed to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Oramed undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Oramed, reference is made to Oramed’s reports filed from time to time with the U.S. Securities and Exchange Commission.

Company Contact

Oramed Pharmaceuticals
Josh Hexter
1 844 9 ORAMED ext. 2
Email:  josh@oramed.com

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