Bachem has the experience and the financial resources to meet growing regulatory and GMP demands. We have also submitted dozens of technical packages in support of successful IMPD and IND applications.

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Liao, F. Herbs of activating blood circulation to remove blood stasis. Clin Hemorheol Microcirc. 23, 127–131 (2000).

        Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

In the second part (clinically-based), subjects will continue with the same treatment assignment until study completion to determine clinical efficacy. The primary clinically-based endpoint is expected to be based on clinical events including all-cause mortality, histological progression to cirrhosis, MELD score >15, and hepatic decompensation events (e.g., hepatic encephalopathy, variceal bleeding, ascites). If the clinical trial results in the first part are positive, we plan to submit an NDA for conditional approval to the FDA.

        Issued patents that we have or may obtain or license may not provide us with any meaningful protection, prevent competitors from competing with us or otherwise provide us with any competitive advantage. Our competitors may be able to circumvent our patents by developing similar or alternative technologies or products in a non-infringing manner. Our competitors may also seek approval to market their own products similar to or otherwise competitive with our products. Alternatively, our competitors may seek to market generic versions of any approved products by submitting ANDAs to the FDA in which they claim that patents owned or licensed by us are invalid, unenforceable or not infringed. In these circumstances, we may need to defend or assert our patents, or both, including by filing lawsuits alleging patent infringement. In any of these types of proceedings, a court or other agency with jurisdiction may find our patents invalid or unenforceable, or that our competitors are competing in a non-infringing manner. Thus, even if we have valid and enforceable patents, these patents still may not provide protection against competing products or processes sufficient to achieve our business objectives.

        Intangible assets are amortized over the pattern in which the economic benefits of the intangible assets are utilized, over an estimated useful life of approximately nine years.

This could also apply with respect to data privacy. In the EU, the EU Directive 95/46/EEC was replaced by the GDPR on May 25, 2018. The GDPR as an EU regulation does not have to be implemented into Member States’ national law, but applies directly in all Member States since May 25, 2018. It applies to companies with an establishment in the European Economic Area (EEA) and to certain other companies not in the EEA that offer or provide goods or services to individuals located in the EEA or monitor individuals located in the EEA. The GDPR implements more stringent operational requirements for controllers of personal data, including, for example, expanded disclosures about how personal information is to be used, limitations on retention of information, increased requirements pertaining to health data and pseudonymized (i.e., key-coded) data, increased cyber security requirements, mandatory data breach notification requirements and higher standards for controllers to demonstrate that they have obtained a valid legal basis for certain data processing activities. The GDPR provides that EU Member States may continue to make their own further laws and regulations in relation to the processing of genetic, biometric or health data, which could result in continued or new differences between Member States, limit our ability to use and share personal data or could cause our costs to increase, and harm our business and financial condition. We are also subject to evolving and strict rules on the transfer of personal data out of the European Union to the United States. Further prospective revision of the Directive on privacy and electronic communications (Directive 2002/58/EC), or ePrivacy Directive, may affect our marketing communications.

An eighth family and a ninth family, both having PCT International Applications filed in 2017 and two pending US applications, are directed to uses of Aramchol for treating and inhibiting fibrosis. The two PCT Applications will enter National Phase by May 2019. If granted and the appropriate maintenance, renewal, annuity or other governmental fees are paid, the non-extended term of this patent family is due to expire on November 10, 2037. In addition, a US Continuation-in-part claiming priority to all of the above applications was filed in November 2018 and claims the treatment and inhibition of fibrosis by a regimen of 300 mg of Aramchol twice daily. The improved bio-availability of Aramchol is supported by the pharmacological model based on the preclinical and the ARREST data.

The H&E staining revealed that blood vessel endothelium in the normal group was integrated, but was not integrated in the model group. β-BA protected endothelium from the injury (Fig. 2). In addition, counts of circulating endothelial cells was performed. The results clearly showed that β-BA treatment significantly diminished circulating endothelial cells (CEC) count in blood compare to model (see Supplementary Fig. S1 online). The levels of NO and cGMP were determined in rats’ carotid aortas. β-BA significantly increased both the product of NO and cGMP in a dose-dependent manner (Fig. 3a,b). Moreover, NO production was directly investigated in cultured HUVECs by referring to NO indicator DAF-FM DA (Fig. 3c,d). Application of β-BA triggered a progressive rise in intracellular NO production in cultured HUVECs, as reflected by the increase of fluorescence intensity. The present results strongly indicate that β-BA could dose-dependently elevate the NO production in HUVECs.

Valsartan is an angiotensin-II-receptor antagonist used to treat hypertension (high blood pressure), recent heart attack, and heart failure. 

We conducted the food effect and PK study at the Sourasky Medical Center in Tel Aviv, Israel involving 66 healthy volunteers to evaluate the PK of Aramchol following single and multiple escalating doses (200 mg, 400 mg and 600 mg), as well as to evaluate the effect of a high-fat, high-calorie meal on the PK of Aramchol following a single dose in healthy volunteers.