VANCOUVER, British Columbia--(BUSINESS WIRE)--Lobe Sciences Ltd. (CSE: LOBE) (OTCQB: LOBEF) ("Lobe" or the "Company"), a biopharmaceutical company focused on developing transformative medicines to treat orphan diseases today announced it has entered into a commercial distribution agreement for the supply and distribution of Altemia™ with Pentec Health, Inc. (“Pentec Health”), a nationwide provider of clinical nutrition and specialty care services addressing complex needs for patients. Altemia™ is Lobe’s proprietary formulation of emulsified docosahexaenoic acid ethyl ester (“DHA”) concentration designed for patients with sickle cell disease (“SCD”).
Under the terms of the distribution agreement, Pentec Health will receive the exclusive rights to distribute Altemia™ in the United States and US territories. Through Pentec Health, Altemia™ will be available to pediatric and adult patients with SCD throughout the United States.
This agreement is the first step in the global launch of Altemia™, which will be available as a medical food for the replacement of DHA in SCD patients in the United States. It is the first medical food in the United Sates designed specifically to support patients with SCD. Previous studies have demonstrated beneficial outcomes for patients while taking the primary component of Altemia™ under physician supervision, including a reduction in vaso-occlusive crises, reduction in hospital visits and improvement in critical biomarkers of inflammation1, 2.
Altemia™ is manufactured by our exclusive cGMP partner headquartered in the United States. It is expected that Altemia™ will be available to patients in the United States by the second half of 2023.
Philip Young, CEO of Lobe commented, “We are pleased to be working with Pentec Health to provide Altemia™ to this underserved but significant unmet patient need in children and adults suffering from SCD. Pentec Health is extremely well-positioned and experienced in the medical food marketplace and they will ensure it reaches key healthcare providers and patients. Leveraging its previous success managing distribution and payer interactions in the Medical Food market, working with Pentec Health will ensure a smooth launch of Altemia™.”
Matthew Deans, CEO & President of Pentec Health, added, “In our mission to solve complex care challenges, the partnership with Lobe, to both distribute and provide patient support services for Altemia™, strengthens our clinical nutrition platform and bolsters our medical food offering. This collaboration to distribute Altemia™ will support Lobe in their efforts to get this important treatment to patients and caregivers. With our collective efforts alongside the physician and SCD community, we anticipate making a profound impact on the lives of sickle cell disease families across the United States.”
About Altemia™
Altemia™, a Medical Food, is a proprietary oral formulation of emulsified docohexanoic acid (DHA) clinically evaluated to restore DHA levels and help reduce inflammation associated with SCD.
About Sickle Cell Disease
Sickle cell disease is a group of inherited red blood cell disorders that affect hemoglobin, the protein that carries oxygen through the body. The condition affects more than 100,000 people in the United States and 20 million people worldwide. In the U.S., SCD is most common among Black Americans, occurring in one of every 365 births. People with Middle Eastern and South Asian ancestry are also susceptible to the disease and some 45 million people around the world carry a gene for the condition, which they can pass along to their children.
In SCD patients, DHA, an essential fatty acid can metabolize by interaction with HbSS hemoglobin (not normal hemoglobin) and this metabolism results in DHA deficiency. DHA deficiency causes red blood cells to become inflamed and destroyed when the membrane breaks. This error in metabolism may be corrected by taking high amounts of DHA1,2.
Normally, red blood cells are disc-shaped and flexible enough to move easily through the blood vessels. If you have sickle cell disease, your red blood cells are crescent- or “sickle”-shaped. These cells do not bend or move easily and can block blood flow to the rest of your body. The blocked blood flow through the body can lead to serious problems, including stroke, eye problems, infections, and episodes of pain called pain crises.
- Daak, A. et al. (2020). Biochemical and therapeutic effects of Omega-3 fatty acids in sickle cell disease. Complementary Therapies in Medicine, 52, 183-188.
- Wandersee, N. et al. (2015). Dietary supplementation with docosahexanoic acid (DHA) increases red blood cell membrane flexibility in mice with sickle cell disease. Blood Cells, Molecules, and Diseases, 54(2), 183-188.
About Pentec Health
For 40 years, Pentec Health has been an industry leader in providing patient-specific, compounded sterile medications. Pentec Health provides clinical nutrition formulations that are administered to patients in dialysis centers and provides in-home Intrathecal nursing services and complex pharmaceutical products to patients who require access outside of a hospital setting. Pentec Health has built a tradition of exceptional patient care by committing to quality, safety, and innovation. Pentec Health aims to be the provider of choice for outsourced products, sterile preparations, and services in the healthcare marketplace. For more information, please visit http://www.pentechealth.com.
About Lobe Sciences Ltd.
Lobe Sciences is a biopharmaceutical company focused on developing transformative medicines to treat orphan diseases. The Company, through collaborations with industry-leading partners, is additionally engaged in drug research and development using sub-hallucinatory doses of psychedelic compounds to address unmet medical needs in orphan neurological therapeutic applications.
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Forward Looking Statements
This news release contains forward-looking statements relating to the future operations of the Company and other statements that are not historical facts. Forward-looking statements are often identified by terms such as "will", "may", "should", "anticipate", "expects" and similar expressions. All statements other than statements of historical fact included in this news release (including, without limitation, statements regarding the future plans and objectives of the Company, research and development using psychedelic compounds, and the development of innovative devices and delivery mechanisms to improve mental health and wellness) are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate, and actual results and future events could differ materially from those anticipated in such statements. Readers are cautioned that assumptions used in the preparation of the forward-looking statements may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company, including changes to the regulatory environment; that the Company's drug research and development activities may be unsuccessful; that drugs and medical devices produced by, or on behalf of, the Company, may not work in the manner intended or at all, and may subject the Company to product liability or other liability claims; that the Company may not be able to attain the Company's corporate goals and objectives; and other risk factors detailed in the Company's continuous disclosure filings from time to time, as available under the Company's profile at www.sedar.com. As a result, the Company cannot guarantee that any forward-looking statement will materialize and the reader is cautioned not to place undue reliance on any forward-looking information. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made only as of the date of this news release and the Company does not intend to update any of the included forward-looking statements except as expressly required by applicable Canadian securities laws.
