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Northbrook, sick., May 25, 2021 /PRNewswire/-Today, the Federal Circuit Judge William Bryson, Is the High Circuit Judge of the U.S. Court of Appeals for the Federal Circuit, and was appointed to serve in the U.S. District Court of the U.S. District Court. Delaware, Granting Clarus requirements for Lipocine, Inc. ((“, Lipocine”, NASDAQ:LPCN) Because it failed to provide a sufficient written explanation of the patent claims claimed by Lipocine. Judge Bryson gave Claras a clear victory in his decision, and he determined that all the Lipocine patent claims were invalid. Klaus’s defense of injustice is still awaiting trial by Judge Bryson, and its disposal will be resolved by Klaus and the court in the future.
Lipocine filed a patent infringement lawsuit against Clarus April 2, 2019, Produced by Clarus marketing JATENZO, an oral testosterone replacement product approved by the FDA in March 2019, and launched in March 2020. Lipocine previously dismissed two other Lipocine patent infringement allegations against Clarus.
Dr. Bryan said: “Judge Bryson’s decision was very satisfactory and completely dealt with Liposin’s infringement claims, which Claros considered unfounded from the first day.” Robert DudleyChairman, CEO and President of Clarus. “We thank the court for hearing a reasonable decision in support of Clarus.”
Dr. Dudley added: “Clarus is committed to dedicating all our resources to the development of the best medicines that people can live every day.” “With this decision, Clarus continues to promote its JATENZO marketing and expand its presence. Product lines outside the field of men’s health.”
About Clarus Therapeutics, Inc.
Clarus is a pharmaceutical company with extensive expertise and interest in the development of male and female androgen and metabolic therapies, including potential therapies for orphan indications. Clarus’ first commercial product, JATENZO, was launched in early 2020.For more information, please visit www.clarustherapeutics.com with www.jatenzo.com
Forward-looking statements
Certain statements in this press release are “forward-looking statements” within the meaning of the federal securities laws, including statements about the ability of the parties to complete the proposed business combination and related transactions, the expected benefits of the proposed business combination, and Bluewater and/or the proposed The financial status, operating results, profit prospects and prospects of the business combination and related transactions, and may include statements for the period after the completion of the proposed business combination and related transactions. In addition, any predictions (financial or other), forecasts or other characteristics of future events or circumstances, including any underlying assumptions, are forward-looking statements. Forward-looking statements are usually composed of “plan”, “believe”, “expect”, “expect”, “intend”, “expect”, “estimate”, “forecast”, “project”, “continue”, “may” , “May”, “may”, “potential”, “forecast”, “should”, “may” and other similar words and expressions, but the lack of these words does not mean that the statement is not forward-looking.
Forward-looking statements are based on the current expectations (if applicable) of the management of Blue Water and Clarus Therapeutics. They are inherently subject to uncertainty, environmental changes and their potential impact, and are only on the date of such statements. effective. There is no guarantee that future development will be expected. These forward-looking statements involve many risks, uncertainties or other assumptions. These risks, uncertainties or other assumptions may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements, including: and Clarus Therapeutics increases the risks associated with sales capabilities. JATENZO guarantees a favorable reimbursement range for such sales and expands the product range to include androgen and metabolic therapy product lines for men and women, including orphan indications; completes the proposed business combination and obtains Blue Water’s shareholder approval or satisfaction The ability to deal with other conditions in the final merger agreement; The outcome of any legal proceedings that may be brought against Blue Water or Clarus related to the merger agreement or the proposed transaction; The ability to maintain the listing of Blue Water Securities on the National Stock Exchange; The existing Blue Water Securities The redemption amount for holders of water common stock; The ability to recognize the expected return of the business combination; In the final prospectus of Blue Water in its initial public offering, Blue Water will submit the “in the registration statement on the S-4 form” Other risks and uncertainties under the heading “risk factors” December 16, 2020 And other documents submitted by Blue Water to the SEC.
Media contact:
Russian partners
David Shure
4th Floor, No. 12 West 27th Street
New York, New York 10001
(858) 717-2310
david.schull@russopartnersllc.com
Clarus Investor Relations Contact:
Rick Peterson
Clarus Therapeutics, Inc.
555 Skokie Blvd., Suite 340
Northbrook, 60062
(847) 562-4300
rpeterson@clarustherapeutics.com
About JATENZO
Indications
JATENZO® (Testosterone Undecanoate) Capsules CIII is an androgen that can be used for testosterone replacement therapy in adult men due to endogenous testosterone deficiency or deficiency:
Primary hypogonadism (congenital or acquired): due to cryptorchidism, bilateral torsion, orchitis, disappearance of testicular syndrome, orchiectomy, Klinefelter’s syndrome, chemotherapy or toxic damage caused by alcohol or heavy metals The resulting testicular failure.These men usually have low serum testosterone and gonadotropin (follicle stimulating hormone) concentrations [FSH]Progesterone [LH]) Out of the normal range.
Gonadotropin hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury caused by tumor, trauma or radiation. These people have low testosterone serum concentrations, but normal or low gonadotropin levels.
Use restrictions
The safety and effectiveness of JATENZO in men under 18 have not been established.
Important safety information
Warning: elevated blood pressure
- JATENZO may increase blood pressure (BP), thereby increasing the risk of major adverse cardiovascular events (MACE), including non-fatal myocardial infarction, non-fatal stroke and cardiovascular death.
- Before starting JATENZO, please consider the patient’s baseline cardiovascular risk and ensure that blood pressure is properly controlled.
- Regularly monitor and treat new-onset hypertension or exacerbations of pre-existing hypertension, and re-evaluate whether the benefits of JATENZO in the treatment of patients with cardiovascular risk factors or cardiovascular diseases outweigh their risks.
- Because of this risk, JATENZO is only used to treat men with hypogonadism related to structural or genetic causes.
Contraindications
JATENZO is a contraindication for men with breast cancer or known or suspected prostate cancer. JATENZO is contraindicated in pregnant women because testosterone may cause fetal harm.
Warnings and precautions
- Check the hematocrit before starting use and every 3 months when the patient uses JATENZO. If the hematocrit increases, stop JATENZO until the hematocrit drops to an acceptable level. If the hematocrit increases after JATENZO restarts, please stop permanently.
- Monitor patients with benign prostatic hyperplasia (BPH) who are treated with androgens due to an increased risk of worsening symptoms and signs of androgen-induced benign prostatic hyperplasia (BPH).
- Venous thromboembolic events (VTE) including deep vein thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients using testosterone replacement products (such as JATENZO). Evaluate patients whose symptoms or signs are consistent with DVT or PE. If VTE is suspected, stop JATENZO and begin appropriate examination and management.
- Testosterone has been abused, usually in higher doses than recommended for approved indications and combined with other anabolic androgenic steroids.
- Large doses of androgens can inhibit spermatogenesis through feedback inhibition of pituitary FSH. Before prescribing JATENZO, patients should be informed of this risk.
- Long-term use of high-dose methyltestosterone has caused serious liver adverse events. It is unknown that JATENZO can cause these adverse events. However, patients should be instructed to report any signs of liver insufficiency, and JATENZO should be discontinued when evaluating the cause.
- Edema with or without congestive heart failure can be a serious complication for patients suffering from heart disease, kidney disease, or liver disease. In addition to discontinuation of the drug, diuretic therapy may be required.
- Gynecomastia may develop and persist in patients with hypogonadism.
- Some patients may experience sleep apnea, especially those with risk factors such as obesity or chronic lung disease.
- Changes in serum lipid profile may require adjustment of the dose of lipid-lowering drugs or termination of testosterone therapy. Monitor lipid status regularly, especially after starting testosterone therapy.
- For cancer patients at risk of hypercalcemia, please use JATENZO with caution. Serum calcium concentration was monitored regularly during treatment with JATENZO in these patients.
- Androgens, including JATENZO, may reduce the concentration of thyroxine-binding globulin, thereby reducing the total T4 serum concentration and increasing the resin intake of T3 and T4. The free thyroid hormone concentration remains unchanged, but there is no clinical evidence of thyroid dysfunction.
- In clinical trials, there have been reports of depression and suicidal ideation in patients treated with JATENZO.
Adverse events
The most common adverse events (incidence ≥ 2%) of JATENZO were headache (5%), increased hematocrit (5%), hypertension (4%), decreased HDL (3%) and nausea (2%).
These are not all risks associated with JATENZO. For more information, click here for complete prescription information, including a boxed warning about increased blood pressure. You can also get information about Jatenzo at: www.jatenzo.com.
©2021 Clarus Therapeutics, Inc. All rights reserved.
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SOURCE Clarus Therapeutics
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